US7682338B2 - Infusion medium delivery system, device and method with needle inserter and needle inserter device and method - Google Patents

Abstract

An infusion medium delivery system, device and method for delivering an infusion medium to a patient-user, includes a needle inserter device and method for inserting a needle and/or cannula into a patient-user to convey the infusion medium to the patient-user. The needle inserter device and method operate to insert a needle and cannula into a patient-user's skin and automatically withdraw the needle from the patient-user, leaving the cannula in place and in fluid flow communication with a reservoir. The delivery device may include a base portion and a durable portion connectable to the base portion, and wherein the base portion can be separated from the durable portion and disposed of after one or more specified number of uses. The base portion supports the reservoir and the needle inserter device, while the durable portion supports a drive device for selectively driving the infusion medium out of the reservoir and into the needle and/or cannula.

Description

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS

The present invention relates to U.S.Provisional Patent Application 60/839,840, filed Aug. 23, 2006 and U.S.Provisional Patent Application 60/854,829, filed Oct. 27, 2006, each of which is incorporated herein in its entirety and forms a basis for a claim of priority. The present invention also relates to U.S.Patent Application 60/678,290, filed May 6, 2005 and U.S. patent application Ser. No. 11/211,095, filed Aug. 23, 2005, titled “Infusion Device And Method With Disposable Portion,” each of which is incorporated herein by reference in its entirety. The present invention further relates to application No. 60/839,822, filed Aug. 23, 2006, entitled “Infusion Medium Delivery Device And Method For Driving Plunger In Reservoir”; application No. 60/839,832, filed Aug. 23, 2006, titled “Infusion Medium Delivery Device And Method With Compressible Or Curved Reservoir Or Conduit”; application No. 60/839,741, filed Aug. 23, 2006, titled “Infusion Pumps And Methods And Delivery Devices And Methods With Same”; and application No. 60/839,821, filed Aug. 23, 2006, titled “Systems And Methods Allowing For Reservoir Filling And Infusion Medium Delivery”, the contents of each of which is incorporated herein by reference, in its entirety. Embodiments of the present invention also relate to: (i) U.S. patent application Ser. No. 11/588,832, filed Oct. 27, 2006, entitled “Infusion Medium Delivery Device and Method with Drive Device for Driving Plunger in Reservoir”; (ii) U.S. patent application Ser. No. 11/588,847, filed Oct. 27, 2006, entitled “Infusion Medium Delivery Device and Method with Compressible or Curved Reservoir or Conduit”; (iii) U.S. patent application Ser. No. 11/588,875, filed Oct. 27, 2006, entitled “Systems And Methods Allowing For Reservoir Filling And Infusion Medium Delivery”; and (iv) U.S. patent application Ser. No. 11/589,323, filed Aug. 23, 2006, entitled “Infusion Pumps and Methods and Delivery Devices and Methods with Same”; (v) U.S. patent application Ser. No. 11/602,173, filed Nov. 20, 2006, entitled “Systems and Methods Allowing for Reservoir filling and Infusion Medium Delivery”; (vi) U.S. patent application Ser. No. 11/602,052, filed Nov. 20, 2006, entitled “Systems and Methods Allowing for Reservoir filling and Infusion Medium Delivery”; (vii) U.S. patent application Ser. No. 11/602,428, filed Nov. 20, 2006, entitled “Systems and Methods Allowing for Reservoir filling and Infusion Medium Delivery”; (viii) U.S. patent application Ser. No. 11/602,113, filed Nov. 20, 2006, entitled “Systems and Methods Allowing for Reservoir filling and Infusion Medium Delivery”; (ix) U.S. patent application Ser. No. 11/604,172, filed Nov. 22, 2006, entitled “Infusion Medium Delivery Device and Method and Drive Device for Driving Plunger in Reservoir”; (x) U.S. patent application Ser. No. 11/604,171, filed Nov. 22, 2006, entitled “Infusion Medium Delivery Device and Method and Drive Device for Driving Plunger in Reservoir”, the contents of each of which are incorporated by reference herein, in their entirety.

FIELD OF THE INVENTION

Embodiments of the present invention relate to an infusion medium delivery system, device and method for delivering an infusion medium to a patient-user, including a needle inserter device and method for inserting a needle and/or cannula into a patient-user for conveying the infusion medium to the patient-user. Further embodiments relate to the needle inserter device and method, whether or not included in an infusion medium delivery system, device or method. According to some embodiments as described herein, the delivery device may include a disposable portion and a durable portion connectable to the disposable portion, and wherein the base portion can be separated from the durable portion and disposed of after one or more specified number of uses. The disposable portion supports a reservoir, while the durable portion supports a drive device for selectively driving the infusion medium out of the reservoir and into the needle and/or cannula.

BACKGROUND OF THE INVENTION

Certain chronic diseases may be treated, according to modern medical techniques, by delivering a medication or other substance to a patient-user's body, either in a continuous manner or at particular times or time intervals within an overall time period. For example, diabetes is a chronic disease that is commonly treated by delivering defined amounts of insulin to the patient-user at appropriate times. Some common modes of providing an insulin therapy to a patient-user include delivery of insulin through manually operated syringes and insulin pens. Other modern systems employ programmable pumps to deliver controlled amounts of insulin to a patient-user.

Pump type delivery devices have been configured in external devices (that connect to a patient-user) or implantable devices (to be implanted inside of a patient-user's body). External pump type delivery devices include devices designed for use in a generally stationary location (for example, in a hospital or clinic), and further devices configured for ambulatory or portable use (to be carried by a patient-user). Examples of some external pump type delivery devices are described in U.S. patent application Ser. No. 11/211,095, filed Aug. 23, 2005, titled “Infusion Device And Method With Disposable Portion” and Published PCT Application WO 01/70307 (PCT/US01/09139) titled “Exchangeable Electronic Cards For Infusion Devices” (each of which is owned by the assignee of the present invention), Published PCT Application WO 04/030716 (PCT/US2003/028769) titled “Components And Methods For Patient Infusion Device,” Published PCT Application WO 04/030717 (PCT/US2003/029019) titled “Dispenser Components And Methods For Infusion Device,” U.S. Patent Application Publication No. 2005/0065760 titled “Method For Advising Patients Concerning Doses Of Insulin,” and U.S. Pat. No. 6,589,229 titled “Wearable Self-Contained Drug Infusion Device,” each of which is incorporated herein by reference in its entirety.

External pump type delivery devices may be connected in fluid-flow communication to a patient-user, for example, through a suitable hollow tubing. The hollow tubing may be connected to a hollow needle that is designed to pierce the patient-user's skin and deliver an infusion medium to the patient-user. Alternatively, the hollow tubing may be connected directly to the patient-user as or through a cannula or set of micro-needles.

In contexts in which the hollow tubing is connected to the patient-user through a hollow needle that pierces the patient-user's skin, a manual insertion of the needle into the patient-user can be somewhat traumatic to the patient-user. Accordingly, insertion mechanisms have been made to assist the insertion of a needle into the patient-user, whereby a needle is forced by a spring to quickly move from a retracted position into an extended position. Examples of insertion mechanisms that are built into a delivery device are described in U.S. patent application Ser. No. 11/211,095, filed Aug. 23, 2005, titled “Infusion Device And Method With Disposable Portion” (assigned to the assignee of the present invention), which is incorporated herein by reference in its entirety. Other examples of insertion tools are described in U.S. Patent Application Publication No. 2002/0022855, titled “Insertion Device For An Insertion Set And Method Of Using The Same” (assigned to the assignee of the present invention), which is incorporated herein by reference in its entirety. Other examples of needle/cannula insertion tools that may be used (or modified for use) to insert a needle and/or cannula, are described in, for example U.S. patent application Ser. No. 10/389,132 filed Mar. 14, 2003, and entitled “Auto Insertion Device For Silhouette Or Similar Products,” and/or U.S. patent application Ser. No. 10/314,653 filed Dec. 9, 2002, and entitled “Insertion Device For Insertion Set and Method of Using the Same,” both of which are incorporated herein by reference in their entirety. As the needle is moved into the extended position, the needle is quickly forced through the patient-user's skin in a single, relatively abrupt motion that can be less traumatic to certain patient-users as compared to a slower, manual insertion of a needle. While a quick thrust of the needle into the patient-user's skin may be less traumatic to some patient's than a manual insertion, it is believed that, in some contexts, some patients may feel less trauma if the needle is moved a very slow, steady pace.

As compared to syringes and insulin pens, pump type delivery devices can be significantly more convenient to a patient-user, in that accurate doses of insulin may be calculated and delivered automatically to a patient-user at any time during the day or night. Furthermore, when used in conjunction with glucose sensors or monitors, insulin pumps may be automatically controlled to provide appropriate doses of infusion medium at appropriate times of need, based on sensed or monitored levels of blood glucose.

Pump type delivery devices have become an important aspect of modem medical treatments of various types of medical conditions, such as diabetes. As pump technologies improve and doctors and patient-users become more familiar with such devices, the popularity of external medical infusion pump treatment increases and is expected to increase substantially over the next decade.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a generalized diagram of a delivery system in relation to a human patient-user.

FIG. 2 is a perspective view of a delivery device according to an embodiment of the invention.

FIG. 3 is a perspective view of a durable portion and a disposable portion of the delivery device ofFIG. 2, with the durable portion separated from the disposable portion.

FIG. 4 is a schematic, cross-sectional view of a needle inserter device within the delivery device ofFIGS. 2 and 3, according to an embodiment of the invention, wherein a needle and a cannula are each in a retracted position.

FIG. 5 is a schematic, cross-sectional view of the needle inserter device ofFIG. 4, wherein the needle and cannula are each in a partially extended position.

FIG. 6 is a schematic, cross-sectional view of the needle inserter device ofFIG. 4, wherein the cannula is in a fully extended position and the needle is in a retracted position.

FIG. 7 a schematic, cross-sectional view of a needle inserter device within the delivery device ofFIGS. 2 and 3, according to another embodiment of the invention, wherein a needle and a cannula are each in a retracted position.

FIG. 8 is a schematic, cross-sectional view of the needle inserter device ofFIG. 7, wherein the cannula is in a fully extended position and the needle is in a retracted position.

FIG. 9 a schematic, cross-sectional view of a needle inserter device within the delivery device ofFIGS. 2 and 3, according to another embodiment of the invention, wherein a needle and a cannula are each in a retracted position.

FIG. 10 is a schematic, cross-sectional view of the needle inserter device ofFIG. 9, wherein the needle and cannula are each in an extended position.

FIG. 11 is a perspective view of a needle inserter device according to another embodiment of the invention, wherein a needle and a cannula are each in a retracted and ready-to-be activated position.

FIG. 12 is a side view of the needle inserter device embodiment ofFIG. 11, wherein the cannula is in an extended position and the needle is in a retracted position.

FIG. 13 is a perspective view of the needle inserter embodiment ofFIG. 12.

FIG. 14 a schematic, cross-sectional view of a needle inserter device within the delivery device ofFIGS. 2 and 3, according to another embodiment of the invention, wherein a needle and a cannula are each in a retracted position.

FIG. 15 is a schematic, cross-sectional view of the needle inserter device ofFIG. 14, wherein the needle and cannula are each in a partially extended position.

FIG. 16 is a schematic, cross-sectional view of the needle inserter device ofFIG. 14, wherein the cannula is in a fully extended position and the needle is in a retracted position.

FIG. 17 is a side-perspective view of a portion of a delivery device having a needle inserter device according to a further embodiment of the present invention.

FIG. 18 is a schematic cross section view of a cannula and cannula nest component for use with the embodiment ofFIG. 17.

FIG. 19 is a schematic cross-section view of an external needle injector having a cannula and cannula nest ofFIG. 18 aligned for operation with a delivery device having a needle inserter ofFIG. 17.

FIGS. 20-23, each show a side view of a needle inserter device according to a further embodiment, in various positions.

FIGS. 24 and 25 show a perspective view of a needle inserter device according to a further embodiment, in a retracted or start position and in an extended position, respectively.

FIGS. 26 and 27 show a perspective view of a needle inserter device according to a further embodiment, in a retracted or start position and in an extended position, respectively.

FIGS. 28 and 30 each show a perspective view of a needle inserter device according to a further embodiment, in various positions.

FIGS. 29 and 31 each show a cross-sectional view of the needle inserter device according toFIGS. 28 and 30, respectively.

FIG. 32 shows a schematic side view of an arrangement of a durable housing portion and disposable housing portion of a delivery system according to an embodiment of the invention consistent with the embodiment ofFIG. 3.

FIG. 33 shows a schematic side view of an arrangement of a durable housing portion and a disposable housing portion of a delivery system according to another embodiment of the invention.

FIG. 34 shows a schematic top view of an arrangement of a durable housing portion and a disposable housing portion of a delivery system according to an embodiment of the invention.

FIG. 35 shows a schematic top view of an arrangement of a durable housing portion and a disposable housing portion of a delivery system according to another embodiment of the invention.

FIGS. 36 and 37 show a perspective view of a connection arrangement for a disposable housing portion and an injection site module.

FIGS. 38 and 39 show a perspective view of another connection arrangement for a disposable housing portion and an injection site module.

FIGS. 40 and 41 show a perspective view of yet another connection arrangement for a disposable housing portion and an injection site module.

FIG. 42 is a cross-section view of a hollow needle and hydrophobic stop member for priming a hollow needle or cannula of a needle injector device, according to an embodiment of the invention.

FIG. 43 is a side, schematic view of a hollow needle in a needle set having a hydrophobic material for priming.

DETAILED DESCRIPTION

The present invention relates, generally, to needle inserter devices and methods and delivery systems, devices and methods that include such needle inserter devices and methods, for delivering an infusion medium to a recipient, such as a medical patient. The needle inserter device and method may operate to insert a hollow needle or cannula through a patient-user's skin, to provide a fluid flow path for conveying an infusion medium through the hollow needle or cannula and into the patient-user. Embodiments of the present invention may be configured, as described herein, to provide a reliable, cost effective and easy-to-use mechanism for inserting a hollow needle or cannula to a specific depth into a patient-user with minimal traumatic effect.

In addition, embodiments may be configured to establish a contiguous fluid-flow passage for fluid transfer between a reservoir and the patient-user, when the hollow needle or cannula is inserted into the patient-user. Needle inserter devices according to embodiments of the present invention may be incorporated in a delivery device and share a portion of the delivery device housing with other components of the delivery device. In other embodiments, needle inserter devices and methods described herein may be employed in housing structures located external to a delivery device and connected to the delivery device, for example, through a fluid-flow conduit.

In particular embodiments, a delivery device includes first and second housing portions (referred to herein as a durable housing portion and a disposable housing portion, respectively) that are configured to engage and attach to each other for operation. The disposable housing portion may contain or otherwise support a needle inserter device, an infusion medium reservoir and other components that come into contact with the infusion medium and/or the patient-user during operation.

The disposable housing portion may be disengaged and separated from the durable housing portion, such that the disposable housing portion may be readily disposed of after it has been in use for a period of time, or after one or a prescribed number of uses. After disengagement and separation from a disposable housing portion, the durable housing portion may be engaged and operatively connected to another disposable housing portion (such as a new, user-filled, pre-filled, refurbished, refilled or re-manufactured disposable housing portion) for further operation. The durable housing portion may contain or otherwise support components that do not come into contact with the infusion medium or the patient-user during normal operation of the delivery device, including, but not limited to, a drive device, drive linkage, electronic circuits and, in some embodiments, a power source.

While embodiments of the present invention are described herein with reference to an insulin delivery example for treating diabetes, other embodiments of the invention may be employed for delivering other infusion media to a patient-user for other purposes. For example, further embodiments of the invention may be employed for delivering other types of drugs to treat diseases or medical conditions other than diabetes, including, but not limited to drugs for treating pain or certain types of cancers, pulmonary disorders or HIV. Further embodiments may be employed for delivering media other than drugs, including, but not limited to, nutritional media including nutritional supplements, dyes or other tracing media, saline or other hydration media, or the like. Also, while embodiments of the present invention are described herein for delivering or infusing an infusion medium to a patient-user, other embodiments may be configured to draw a medium from a patient-user.

Furthermore, while embodiments of the present invention refer to the housing portions of disclosed delivery devices as disposable or durable, and may be configured to allow the disposable housing portion to be disposed of and replaced in an economically efficient manner, it will be understood that, in further embodiments, the disposable housing portion embodiments described herein may be re-used and need not be disposed of. Similarly, the durable housing portion embodiments described herein may be disposed of after one or more uses, if desired. However, embodiments are configured to allow certain components (for example, those that contact the infusion medium or the patient-user during operation) to be housed in a first housing portion that may be readily disposable, while other components (for example, those that do not contact the infusion medium or the patient-user during operation and that have a replacement cost that is of a relatively significant level) may be housed in a second housing portion that may be re-used with one or more new, user-filled, prefilled, refilled, refurbished or remanufactured disposable first housing portions. Also, while delivery device embodiments of the present invention include multiple housing portions, such as a disposable housing portion and a durable housing portion, other delivery device embodiments may employ a single housing structure that includes, among other features, a needle inserter device as described below. Yet other embodiments may employ an injection site module that contains a needle injector device and that connects to a further housing (such as the disposable housing portion) of a delivery device, as described below.

A generalized representation of an infusionmedium delivery system10 is shown inFIG. 1, wherein the system includes adelivery device12 configured according to an embodiment of the invention described herein. Thesystem10 may also include other components coupled for communication with thedelivery device12, including, but not limited to, a sensor or monitor14, a command control device (CCD)16 and acomputer18. Each of theCCD16, thecomputer18, the sensor or monitor14 and thedelivery device12 may include receiver or transceiver electronics that allow communication with other components of the system. While the sensor or monitor14 inFIG. 1 is shown as a separate element relative to thedelivery device12 and connected thereto through a communication link, in other embodiments, the sensor or monitor14 may be incorporated within thedelivery device12. Thedelivery device12 may include electronics and software for analyzing sensor data and for delivering an infusion medium according to sensed data and/or pre-programmed delivery routines. Some of the processing, delivery routine storage and control functions may be carried out by theCCD16 and/or thecomputer18, to allow thedelivery device12 to be made with more simplified electronics. However, in other embodiments, thesystem10 may includedelivery device12 that operates without any one or more of the other components of thesystem10 shown inFIG. 1. Examples of the types of communications and/or control capabilities, as well as device feature sets and/or program options may be found in U.S. patent application Ser. No. 10/445,477 filed May 27, 2003, and entitled “External Infusion Device with Remote Programming, Bolus Estimator and/or Vibration Alarm Capabilities,” and U.S. patent application Ser. No. 10/429,385 filed May 5, 2003, and entitled “Handheld Personal Data Assistant (PDA) with a Medical Device and Method of Using the Same,” U.S. patent application Ser. No. 09/813,660 filed Mar. 21, 2001, and entitled “Control Tabs For Infusion Devices And Methods Of Using The Same,” all of which are incorporated herein by reference in their entirety.

In the generalized system diagram ofFIG. 1, thedelivery device12 and sensor or monitor14 are secured to a patient-user1. The locations at which those components are secured to the patient-user1 inFIG. 1 are provided only as a representative, non-limiting example. Thedelivery device12 and sensor or monitor14 may be secured at other locations on the patient-user1 (including, but not limited to, other locations on the patient-user's skin, clothing, belt, suspenders, straps, purse or other carriable holder), and such locations may depend upon the type of treatment to be administered by thesystem10.

As described in further detail below, thedelivery device12 includes a reservoir containing an infusion medium and delivers the infusion medium, such as, but not limited to an insulin formulation, into the patient-user's body in a controlled manner. Control instructions and/or data may be communicated between thedelivery device12, the sensor or monitor14, theCCD16 and thecomputer18. Thedelivery device12 may be configured to secure to the skin of a patient-user1, in the manner of a patch, at a desired location on the patient-user. In such embodiments, it is desirable that thedelivery device12 have relatively small dimensions for comfort and ability to conceal the device, for example, under a garment.

Examples of patch-like delivery devices are described in U.S. patent application Ser. No. 11/211,095, filed Aug. 23, 2005, U.S. Patent Application No. 60/839,822, filed Aug. 23, 2006, titled “Infusion Medium Delivery Device And Method For Driving Plunger In Reservoir”, U.S. Patent Application No. 60/839,832, filed Aug. 23, 2006, titled “Infusion Medium Delivery Device And Method With Compressible Or Curved Reservoir Or Conduit”, and U.S. Patent Application No. 60/839,741, filed Aug. 23, 2006, titled “Infusion Pumps And Methods And Delivery Devices And Methods With Same”, each of which is incorporated herein, in its entirety. A delivery device according to embodiments of the present invention may be configured in accordance with any one of the delivery devices described in the above-referenced patent applications, and further includes a needle inserter device according to needle inserter embodiments described herein. A delivery device according to further embodiments of the present invention may be configured in accordance with other suitable delivery device designs, and further includes or is connected with a needle inserter device according to needle inserter embodiments described herein.

An example of adelivery device12 according to an embodiment of the present invention is shown inFIG. 2. Thedelivery device12 includes abase housing portion20 that, in some embodiments, may be disposable after one or a number of specified uses, and afurther housing portion22. For convenience, but without limitation, thebase portion20 is referred to herein as a disposable housing portion or disposable portion, while thefurther housing portion22 is referred to herein as a durable housing portion or durable portion. However, as noted above, in operation, either or bothhousing portions20 or22 may be disposed of or re-used, depending upon the context of use.

Thedisposable housing portion20 may support structural elements that ordinarily contact the patient-user's skin or the infusion medium, during operation of thedelivery device12. On the other hand, thedurable housing portion22 may support elements (including electronics, motor components, linkage components, and the like) that do not ordinarily contact the patient-user or the infusion medium during operation of thedelivery device12. Thus, elements in thedurable housing portion22 of thedelivery device12 are typically not contaminated from contact with the patient-user or the infusion medium during normal operation of thedelivery device12.

In the illustrated embodiment, thedisposable housing portion20 of thedelivery device12 includes a base21 that includes or otherwise supports areservoir retaining portion24 that houses a reservoir. Thedurable housing portion22 may include a housing that secures onto the base21 adjacent thereservoir retaining portion24, and may be selectively removed from thebase21, as shown inFIG. 3. Thedurable housing portion22 may house a suitable drive device, such as an electrically operated motor (not shown inFIG. 2), and drive linkage components (not shown inFIG. 2) for driving fluid out of the reservoir. Thedurable housing portion22 also may house suitable control electronics (not shown inFIG. 2) for controlling the operation of the drive device to drive fluid from the reservoir in a controlled manner. Further embodiments may include other electronics within thedurable housing portion22, such as, but not limited to communication electronics (not shown inFIG. 2) for communicating with the sensor or monitor14, theCCD16, thecomputer18 and/or other components of thesystem10 shown inFIG. 1.

Thebase21 of thedisposable housing portion20 has a bottom surface (facing downward and into the page inFIGS. 2 and 3) that is configured to secure to a patient-user's skin at a desired location on the patient-user. A suitable adhesive may be employed at the interface between the bottom surface of thebase21 and the patient-user's skin, to adhere the base21 to the patient-user's skin. The adhesive may be provided on the bottom surface of thebase21, with apeelable cover layer23 covering the adhesive material. In this manner, a patient-user may peel off thecover layer23 to expose the adhesive material and then place the adhesive side of the base21 against the patient-user's skin.

Thedisposable portion20 may include a button orother operator25 for operating a needle inserter device located within thereservoir retaining portion24. Alternatively, or in addition,reference number25 may represent anopening25, through which an external plunger or another form of operator, may operate the needle inserter device, as described below. The operator oropening25 may be provided in a location that is readily accessible from outside of thedisposable housing portion20, when thedisposable housing portion20 is secured to a patient-user's skin. For example, in the illustrated embodiment, the outer wall on which the operator oropening25 is located is a top wall of the disposable housing portion, facing a direction substantially opposite to the facing direction of the bottom surface that has the adhesive layer andpeelable cover layer23. Alternatively, or in addition to an operator oropening25, the needle inserter device may be activated, through a wireless link, from an external controller, such as theCCD16, sensor or monitor14 orcomputer18. For such embodiments, theCCD16, sensor or monitor14 orcomputer18 includes a wireless signal transmitter, while the delivery device includes a receiver for receiving a wireless actuation signal and an electronic actuator that is controlled to actuate the needle inserter device, upon receipt of an actuation signal from theCCD16, sensor or monitor14 orcomputer18.

Thedurable housing portion22 of thedelivery device12 includes a housing shell configured to mate with and secure to thedisposable housing portion20. Thedurable housing portion22 anddisposable housing portion20 may be provided with correspondingly shaped grooves, notches, tabs or other suitable features that allow the two parts to easily snap together, by manually pressing the two portions together in a manner well known in the mechanical arts. In a similar manner, thedurable housing portion22 anddisposable housing portion20 may be separated from each other by manually applying sufficient force to unsnap the two parts from each other. In further embodiments, a suitable seal, such as an annular seal, may be placed along the peripheral edge of thedisposable housing portion20 and/or thedurable housing portion22, so as to provide a liquid, hermetic, or air-tight seal between thedisposable housing portion20 and thedurable housing portion22.

Thedurable housing portion22 anddisposable housing portion20 may be made of suitably rigid materials that maintain their shape, yet provide sufficient flexibility and resilience to effectively snap together and apart, as described above. The base21 material may be selected for suitable compatibility with the patient-user's skin. For example, thedisposable housing portion20 and thedurable housing portion22 of thedelivery device12 may be made of any suitable plastic, metal, composite material or the like. Thedisposable housing portion20 may be made of the same type of material or a different material relative to thedurable housing portion22. The disposable and durable housing portions may be manufactured by injection molding or other molding processes, machining processes or combinations thereof.

The base21 may be made of a relatively flexible material, such as a flexible silicone, plastic, rubber, synthetic rubber or the like. By forming thebase21 of a material capable of flexing with the patient-user's skin, a greater level of patient-user comfort may be achieved when the base is secured to the patient-user's skin. Also, aflexible base21 can result in an increase in the site options on the patient-user's body at which thebase21 may be secured.

Thedisposable housing portion20 and/or thedurable housing portion22 may include an internal sensor (not shown inFIGS. 2 and 3) for connection to a patient-user, for example, through a needle (not shown inFIGS. 2 and 3) or a set of micro-needles for piercing a patient-user's skin when thedisposable housing portion20 is secured to a patient-user's skin. In such embodiments, a suitable aperture (not shown inFIGS. 2 and 3) may be formed in thebase21, to allow the passage of the sensor needle or micro-needles, when the disposable portion is secured to the patient-user's skin. Alternatively, thedurable housing portion20 of thedelivery device12 may be connected to anexternal sensor14, through a sensor lead, as described with respect to FIG. 2 of U.S. patent application Ser. No. 11/211,095, filed Aug. 23, 2005. The sensor may include any suitable biological sensing device, depending upon the nature of the treatment to be administered by thedelivery device12. For example, in the context of delivering insulin to a diabetes patient, thesensor14 may include a blood glucose sensor. Alternatively, or in addition, one or more environmental sensing devices may be included in or on thedelivery device12, for sensing one or more environmental conditions. In further alternatives, the sensor may be included with as a part or along side the infusion cannula and/or needle, such as for example as shown in U.S. patent Ser. No. 11/149,119 filed Jun. 8, 2005, and entitled “Dual Insertion Set,” which is incorporated herein by reference in its entirety.

As described above, by separating disposable elements of thedelivery device12 from durable elements, the disposable elements may be arranged on thedisposable portion20, while durable elements may be arranged within a separabledurable portion22. In this regard, after one (or a prescribed number) of uses of thedelivery device12, thedisposable portion20 may be separated from thedurable portion22, so that thedisposable portion20 may be disposed of in a proper manner. Thedurable portion22 may, then, be mated with a new (un-used, user-filled, pre-filled, refurbished, re-filled or re-manufactured)disposable portion20 for further delivery operation with a patient-user.

Areservoir28 is located in thereservoir retaining portion24 of thedisposable housing portion20. Thereservoir28 may include a container having an internal volume for containing a fluidic infusion medium, such as, but not limited to an insulin formulation. Thereservoir28 may be made of any material suitably compatible with the infusion medium, including, but not limited to suitable metal, plastic, ceramic, glass, composite material or the like. For example, thereservoir28 may be formed of a plastic material referred to as TOPAS (trademark of Ticona, a subsidiary of Celanese Corporation), such as described in U.S. patent application Ser. No. 11/100,188, filed Apr. 5, 2005 (Publication No. 2005/0197626).

In yet other embodiments, thereservoir28 may be formed unitarily with thereservoir retaining portion24, for example, as a hollow chamber provided within an otherwise solid portion of thereservoir retaining portion24. In such embodiments, the hollow interior of thereservoir retaining portion24 may be coated or lined in another manner with a suitable metal, plastic, plastic TOPAS (trademark of Ticona, a subsidiary of Celanese Corporation), ceramic, glass, composite material or the like. Alternatively, or in addition, the retainingportion24, itself, may be made of a suitable metal, plastic, plastic TOPAS (trademark of Ticona, a subsidiary of Celanese Corporation), ceramic, glass, composite material or the like.

Thereservoir28 has an outlet port (not shown), through which the infusion medium contained within the interior of thereservoir28 may be communicated out of the reservoir. The outlet port is arranged in fluid flow communication with the interior of thereservoir28 and is connected, through any suitable fluid-flow conduit, in fluid flow communication with an injection site. In the embodiment inFIGS. 2 and 3, the injection site is located within thedisposable housing portion20 and is accessible through theopening25. In other embodiments as described below, the injection site may be located external to thedisposable housing portion20 and connected to thereservoir28, through a fluid flow conduit in the form of a flexible tube. In yet other embodiments as described below, the injection site may be located on a base portion to which one or both of thedisposable housing portion20 and thedurable housing portion22 may connect.

The fluid flow conduit may include a fluid-flow path that has a first end in fluid flow communication with the outlet port of the reservoir and a second end in fluid flow communication with the injection site. The injection site may include a needle inserter device as described herein, to assist the insertion of a needle or cannula into the patient-user and connection of the needle or cannula in flow communication with the fluid flow conduit.

An example of aneedle inserter device40 according to an embodiment of the present invention is shown inFIGS. 4-6. Theneedle inserter device40 ofFIGS. 4-6 operates with anexternal plunger device41, described below. Theneedle inserter device40 includes amoveable needle42 supported within ahousing structure44. In the illustrated embodiment, thehousing structure44 may include a portion of the housing structure of thedisposable housing portion20 ofFIGS. 2 and 3. In other embodiments, thehousing structure44 may include the housing structure of another suitable drive device housing or a housing structure that is separate from a drive device housing.

In addition to themoveable needle42, theneedle inserter device40 further includes aneedle carriage46, a hollow needle orcannula48, a furtherhollow needle50, afirst septum52, asecond septum54 and abias member56. Themoveable needle42,needle carriage46 andcannula48 are supported for movement within thehousing44, from a retracted position shown inFIG. 4, to an extended position in the direction ofarrow58, along the axial direction A of theneedle42 andcannula48. In the view ofFIG. 5, themoveable needle42,needle carriage46 andcannula48 are in a partially extended position. In the view ofFIG. 6, themoveable needle carriage46 andcannula48 are in a fully extended position, while themoveable needle42 has been returned to the retracted position. As described below, theneedle inserter device40 operates with anexternal plunger device59, configured to apply a force along the axis A of themoveable needle42 andcannula48, in the direction ofarrow58, to move themoveable needle50,needle carriage46 andcannula48 in the direction ofarrow58.

Theneedle carriage46 is configured to engage one or more (two shown inFIGS. 4-6)engagement pawls60 connected to thehousing44, as theneedle carriage46 moves into the extended position. Upon theneedle carriage46 reaching a fully extended position, each of theengagement pawls60 engage asurface61 of theneedle carriage46. In the illustrated embodiment, thepawls60 include a pair of protruding arms extending inward toward the axis A from a corresponding pair ofstruts62 that extend into the interior of thehousing44, from a bottom wall (relative to the orientation ofFIGS. 4-6) of thehousing44. In a further embodiment, a single,annular strut62 may extend around the circumference of theneedle carriage46 to support a singleannular pawl60 ormultiple pawls60 around the circumference of theneedle carriage46.

Thestruts62 andpawls60 may be configured unitary with thehousing44, such as by forming the unitary structure in a mold and/or machined or otherwise formed from a unitary piece of material. In such an embodiment the pawls may be provided with sufficient flexibility to allow them to flex downward, toward the struts62 (as shown inFIG. 5) by the force of theneedle carriage46, as theneedle carriage46 is moved toward the extended position, and sufficient resilience to return to an unflexed position, upon theneedle carriage46 reaching a position along the direction ofmotion58 at which theengagement surface62 passes thepawls60, as shown inFIG. 6. Alternatively or in addition, thestruts62 may be provided with sufficient pivotal flexibility and resilience to flex or pivot outward (away from the axis A) and allow theneedle carriage46 to sufficiently pass thepawls60, whereupon thestruts62 are allowed to flex or pivot back toward their unflexed or non-pivoted position. When thestruts62 and/orpawls60 are allowed to flex back toward an unflexed state, thepawls60 engage theengagement surface62 of theneedle carriage46, to hold theneedle carriage46 in place, as theneedle42 is returned to a retracted position, also as shown inFIG. 6.

In further embodiments, thepawls60 may be formed as separate members relative to thestruts62, and may be connected to thestruts62 in a manner that allows thepawls60 to flex and/or pivot downward, similar to the downward flex of thepawls60 shown inFIG. 5, for example, through a suitable pivotal or flexible connection structure. A bias spring may be provided within the connection structure to bias thepawls60 toward their unflexed (or non-pivoted) position ofFIG. 4. Also in further embodiments, thestruts62 may be formed as separate structural elements relative to thehousing44 and may be connected in a fixed relation to thehousing44 by any suitable connection structure. Thehousing44, struts62 andpawls60 may be formed of any suitable material having sufficient rigidity and flexibility to perform the functions described herein, such as a plastic, metal, composite material or the like, as described above with respect to thedisposable housing portion20.

Themoveable needle42 includes aneedle head70 and aneedle shaft72. Theneedle head70 andneedle shaft72 may be formed as a unitary structure or as separate structures connected in a fixed relation to each other. In one example embodiment, theneedle head70 includes a round, disk-shaped structure, while theneedle shaft72 includes a cylindrical structure extending from a central axis of the round, disk-shaped head and having a pointed tip for piercing a patient-user's skin. Theneedle42 may be made of any suitable material having sufficient rigidity and biocompatibility to function to pierce a patient-user's skin and operate with other components as described herein, such as, but not limited to NiTi, other metal, plastic, ceramic, composite materials or the like.

Theneedle carriage46 is arranged adjacent (and below, in the orientation ofFIGS. 4-6) theneedle head70. Theneedle carriage46 may include a generally disk-shaped body having acentral passage74 along its axial dimension, through which theneedle shaft72 may extend. Thefirst septum52 is arranged to cover one end of thecentral passage74. In the illustrated embodiment, the disk-shaped body of theneedle carriage46 has arecess76 for containing at least a portion of thefirst septum52, where the recess is located on a surface of the disk-shaped body that faces the needle head. Thefirst septum52 is retained within therecess76 and secured in a fixed relation relative to theneedle carriage46, to allow theneedle shaft72 to pierce the first septum (when theneedle42 andneedle carriage46 are in the position shown inFIGS. 4 and 5), and also allow theneedle shaft72 to be withdrawn from thefirst septum52, when theneedle42 is returned to the retracted position (as shown inFIG. 6). For example, thefirst septum52 may be retained within therecess76 by frictional engagement, adhesive, thermal coupling or other suitable connection structure.

Theneedle carriage46 includes afluid flow passage78 in fluid flow communication with thecentral passage74. The furtherhollow needle50 has a hollow fluid flow path connected in fluid flow communication with thepassage78. Thehollow needle50 extends from the needle carriage46 (downward in the orientation ofFIGS. 4-6), in a direction generally parallel to the axis A of theneedle42 andcannula48, but spaced to one side of the axis A. Thehollow needle50 has a sharp tip that is directed toward thesecond septum54 and positioned to pierce thesecond septum54, as theneedle carriage46 is moved toward the extended position, as shown inFIGS. 5 and 6.

The cannula orhollow needle48 may include a hollow, cylindrical tube-shaped structure. For patient comfort, the outside diameter of thecannula48 may be as small as possible, so that the cannula can be placed through the patient-user's skin, with minimal traumatic effect on the patient-user. The inside diameter of the hollow tube-shaped structure of thecannula48 is larger than the outer diameter of theneedle shaft72, to allow theneedle shaft72 to extend through thecannula48, when theneedle42,needle carriage46 andcannula48 are in the retracted position, as shown inFIG. 4, yet allow the needle to be withdrawn from at least a portion of thecannula48, as described below.

The length of thecannula48 along the axial direction A, is selected to be long enough to extend through a patient-user's skin and to a desired location within the patient-user for delivering the infusion medium, when the cannula is in the extended position, as shown inFIG. 6, yet be short enough (relative to the length of theneedle shaft72, to allow the sharp end of theneedle shaft72 to extend out from the end of the cannula, when theneedle42,needle carriage46 andcannula48 are in the retracted position, as shown inFIG. 4. Thecannula48 may be made of any suitable material having sufficient rigidity and biocompatibility to function as described herein, such as, but not limited to metal, plastic, ceramic, composite materials or the like.

One end of thecannula48 has a flared (enlarged diameter) end that is arranged to remain external to the patient-user, when the cannula is in the extended position as shown inFIG. 6. The flared end of thecannula48 is secured to theneedle carriage46, with the hollow interior of thecannula48 arranged in fluid flow communication with thecentral passage74 of theneedle carriage46. The flared end of thecannula48 may be secured to theneedle carriage46, by any suitable connection structure, including, but not limited to, a friction fit with a funnel-shaped extension of the needle carriage, adhesive, thermal coupling or the like. In further embodiments, the flared shape of the end of thecannula48 may be omitted and thecannula48 may have a constant outer diameter along its entire length.

Thebias member56 is configured to apply a bias force on theneedle42, in the direction opposite to the direction ofarrow58. Thebias member56 may include any suitable structure that provides a bias force on theneedle42, including, but not limited to, a spring configuration, a permanent magnet, an electro-magnet or the like. In the example embodiment ofFIGS. 4-6, thebias member56 includes a coil spring, which is configured to be compressed into a compressed state as shown inFIG. 5 and, when released, to expand to the expanded state shown in each ofFIGS. 4 and 6, when no external force is applied on the needle inserter device. In particular, the coilspring bias member56 may compress to and beyond the state shown inFIG. 5 to allow each of thepawls60 to engage anengagement surface62 of theneedle carriage46, when a sufficient external force is applied to the needle inserter device by theplunger device41 in the direction ofarrow58. The coil spring may be made of any suitable spring material, including, but not limited to, metal, plastic, composite material or the like.

In the embodiment ofFIGS. 4-6, the coilspring bias member56 is arranged around and generally coaxially with the axis A. The coilspring bias member56 extends from theneedle head70 to the top of thestruts62. Anannular groove80 may be provided in the bottom surface (relative to the orientation shown inFIGS. 4-6) of theneedle head70, for receiving a portion of a first end of the coilspring bias member56, to help retain the coilspring bias member56 in place relative to theneedle head70. In some embodiments, the first end of the coil spring may be secured to theneedle head70 by any suitable connection structure including, but not limited to, adhesive, straps, thermal coupling, or the like.

Thestruts62 may include grooves82 (or anannular groove82, for embodiments in which a singleannular strut62 is employed) for receiving a portion of a second end of the coilspring bias member56, to help retain the coilspring bias member56 in place relative to thestruts62. In further embodiments, the first end of the coilspring bias member56 may be secured to theneedle head70 and/or the second end of the coilspring bias member56 may be secured to thestruts62, by any suitable connection structure including, but not limited to, adhesive, straps, thermal coupling, or the like.

The first andsecond septa52 and54 may be made of any suitable material that can be pierced by a needle and form a seal around the needle. The material forsepta52 may be a material that reseals the needle hole after the needle has been removed from septum. Such septum material may include, but is not limited to, a suitable rubber, plastic or the like. As described above, thefirst septum52 is supported on theneedle carriage46, for providing a pierceable seal over one end of thecentral passage74 of theneedle carriage46. Thesecond septum54 is supported by thehousing structure44, adjacent an opening of afluid flow passage84. Thesecond septum54 provides a pierceable seal over thefluid flow passage84. Thefluid flow passage84 may be a channel formed in thehousing structure44, as shown inFIGS. 4-6. In other embodiments, thefluid flow passage84 may include a tube or other conduit structure located within thehousing44. Thefluid flow passage84 is connected, in fluid flow communication, with areservoir connector86.

Thereservoir connector86, may be any suitable connection structure that may be selectively (or, in some embodiments, permanently) connected to areservoir28, to provide fluid flow communication with the interior of thereservoir28. For example, thereservoir connector86 may include a typical Luer-type connector having acap structure88 for receiving an outlet port of the reservoir, ahollow needle90 for piercing aseptum92 within the outlet port of thereservoir28. Thefluid flow passage84 is arranged in fluid flow communication with theneedle90. Accordingly, areservoir28 may be selectively engaged with thecap88, to connect the interior of thereservoir28 in fluid flow communication with thefluid flow passage84, through theneedle90. In other embodiments, theneedle50 andseptum54 may be eliminated and, instead, a continuous flow path (such as, but not limited to, a flexible tubing) may be coupled to thereservoir28 and to thecentral passage74 orpassage78, and able to flex, stretch or otherwise accommodate movement of theneedle carriage46 relative to thehousing structure44 and maintain a fluid flow path between thereservoir28 and thecentral passage78. In yet further embodiments, theconnector86 may be eliminated, for example, by connecting the flexible tubing directly to the reservoir.

Theneedle inserter device12 ofFIGS. 4-6 is configured to insert a hollow needle or cannula into a patient-user's skin, for providing fluid flow communication between thereservoir28 and the patient-user, when the housing structure44 (such as the housing structure of thedisposable housing portion20 inFIGS. 2 and 3) is secured to a patient-user's skin. In operation, theneedle inserter device12 is configured to move between a retracted state (FIG. 4) and an extended state (whereFIG. 5 shows movement toward the extended state). In addition, the needle inserter device has a return state (FIG. 6), at which the hollow needle orcannula48 andneedle carriage46 are in the extended position, while themoveable needle42 is returned to a retracted position.

In one embodiment, anexternal plunger device41 is employed to cause the needle inserter device to move between a retracted state and an extended state. Theplunger41 may include a hand-held, spring-loaded piston device, which is selectively actuated to provide a relatively abrupt piston motion in the direction of thearrow58. In other embodiments, theplunger41 may be controlled to provide a slow needle insertion rate, to minimize traumatic effects to certain patient-users.

For example, theplunger device41 may include a movable plunger having a plunger head that has a size and shape to allow easy insertion into theopening25 in thehousing structure44, to engage theneedle head70. The plunger head is selectively activated to be driven in the direction ofarrow58 and impart a force on theneedle head70, in the direction ofarrow58. The force imparted by theplunger41 on theneedle head70 is sufficient to overcome the bias force of thebias member56, to move theneedle42 in the direction of thearrow58, toward the extended position. The plunger may be spring-loaded, to provide a relatively abrupt motion in the direction ofarrow58, when activated, to move theneedle42 relatively quickly, in the direction ofarrow58.

As theneedle42 is moved downward (with respect to the orientation ofFIGS. 4-6), in the direction ofarrow58, theneedle head70 engages and forces theneedle carriage46 to move with the needle in the direction ofarrow58. As theneedle carriage46 is moved in the direction ofarrow58, thecannula48 attached to theneedle carriage46 is also moved in the direction ofarrow58. As theneedle42 andcannula48 are moved in the direction ofarrow58, the tip of theneedle42 that extends out from thecannula48 pierces the patient-user's skin. As theneedle42 andcannula48 continue to move in the direction toward the extended position, theneedle42 directs a portion of the length of thecannula48 through the patient-user's skin to a desired depth.

As theneedle42 andneedle carriage46 move toward the extended position, the sharp end of the furtherhollow needle50 engages and pierces thesecond septum54, as shown inFIG. 5. When theneedle carriage46 is moved into the fully extended position (as shown inFIG. 6), thehollow needle50 is extended through thesecond septum54, to fluid flow communication between thefluid flow passage84 in thehousing structure44 and thefluid flow passage78 in theneedle carriage46.

Also as theneedle42 andneedle carriage46 move toward the extended position, theneedle carriage46 engages thepawls60 and causes thepawls60 to flex downward (relative to the orientation ofFIG. 5), in the direction ofarrow58, as theneedle carriage46 continues to move toward the extended position. When theneedle carriage46 reaches the extended position (as shown inFIG. 6), thepawls60 return toward their un-flexed state and engage theengagement surface62 of theneedle carriage46, to hold theneedle carriage46 and thecannula48 in their extended position. Once thepawls60 have engaged theengagement surface62 of theneedle carriage46, theplunger41 may be removed by withdrawing the plunger head through theopening25. As theplunger41 is removed, thebias member56 operates to return theneedle42 to the retracted position of the needle, leaving theneedle carriage46 andcannula48 in the extended position, as shown inFIG. 6. As theneedle42 retracts, thefirst septum52 reseals itself.

As a result, thecannula48 will be inserted into the patient-user and also will be connected in fluid flow communication with thereservoir28. Thereafter, infusion medium within thereservoir28 may be selectively delivered to the patient-user, through thecannula48 andfluid flow passages78 and84, by operation of a drive device on thereservoir28, as described above. The patient (or other user) may readily operate the needle inserter device by simple operations of inserting theplunger41 into the opening25 (to engage the plunger with the needle head70), activating the plunger41 (to drive the plunger in the direction of arrow58), and then withdrawing theplunger41 from theopening25.

Aseal structure94 may be provided between theneedle head42 and thehousing structure44, to provide a seal around theopening25. In the embodiment shown inFIGS. 4-6, theseal structure94 may include one or more o-ring seals, gaskets or other suitable seals arranged around theopening25. One or moreannular grooves96 may be provided in the upper surface (relative to the orientation ofFIGS. 4-6) of theneedle head70, for receiving one or more seals. One or moreannular protrusions98 may be provided on an interior surface of thehousing structure44, for engaging the one or more seals, when theneedle42 is in the retracted position, as shown inFIGS. 4 and 6. Alternatively, one ormore seals94 andgrooves96 may be provided on an interior surface of thehousing structure44, while the annular protrusion(s) may be provided on theneedle head70. In further embodiments, a pierceable or removable seal may be provided over the opening through which the needle and cannula extend, when in the extended position. In addition, a seal may be formed between thehousing structure44 and theneedle carriage46, by compression of a portion of the cannula48 (the flared portion shown in the upper end of thecannula48, with respect to the orientation shown inFIG. 6) between thehousing structure44 and theneedle carriage46, when theneedle carriage46 is moved to the extended position (shown inFIG. 6). Accordingly, the cannula48 (or, at least the flared end of thecannula48 that is located between thehousing structure44 and the needle carriage46) may be made of a material that can be compressed to form a seal between thehousing structure44 and theneedle carriage46, when theneedle carriage46 is in the extended position (as inFIG. 6).

While an embodiment of aneedle inserter device40 inFIGS. 4-6 employs anexternal plunger41 for moving theneedle42,needle carriage46 andcannula48 from a retracted position to an extended position, other embodiments may employ internal activation and bias structure for imparting a force to selectively move those components into the retracted position. For example,FIGS. 7 and 8 show an embodiment of aneedle inserter device140 in which a further bias member is selectively actuated to provide a bias force on aneedle142,needle carriage146 andcannula148, in the direction toward an extended position.

The embodiment ofFIGS. 7 and 8 is similar in certain structural and functional respects to the embodiment ofFIGS. 4-6. For example, themoveable needle142,needle carriage146 andcannula148 ofFIGS. 7 and 8 may be similar to theneedle42,needle carriage46 andcannula48 in certain respects. In addition, the embodiment ofFIGS. 7 and 8 include first andsecond septa152 and154 and afurther needle150, similar to the first andsecond septa52 and54 andneedle50 described above (or a flexible tubing instead of thesecond septum54 andneedle50, as described above). For example, theneedle142 includes aneedle head170 andneedle shaft172, similar to theneedle head70 andneedle shaft72 described above. Also, the embodiment ofFIGS. 7 and 8 includeflow channels178 and184, which have similar structure and function as theflow channels78 and84, described above, for providing a fluid flow path between acentral passage174 of theneedle carriage146 and a reservoir (not shown inFIGS. 7 and 8).

However, unlike the embodiment ofFIGS. 4-6, the embodiment ofFIGS. 7 and 8 includes afirst bias member155 for providing a bias force on theneedle carriage146 in the direction ofarrow158, when the needle carriage is in the retracted position shown inFIG. 7. For example, thebias member155 may include a coil spring provided around and generally coaxial with a central axis A of theneedle142 andcannula148. The coilspring bias member155 may be compressed to a compressed state as shown inFIG. 7 and, when released, may expand under its own spring force to an expanded state shown inFIG. 8. A first end of the coilspring bias member155 is abutted against an interior surface of the housing structure144 (which may include a section of thedisposable housing portion20 of the delivery device shown inFIGS. 2 and 3, or may be a housing structure that is separate from the housing structure of the delivery device). The second end of the coilspring bias member155 is abutted against an upper surface (relative to the orientation shown inFIGS. 7 and 8) of theneedle carriage146.

Theneedle carriage146 may include an annular groove for receiving a portion of the second end of the coilspring bias member155, to help retain the coil spring in place with respect to theneedle carriage146. Similarly, an annular groove may be provided in the interior surface of thehousing structure144, for receiving a portion of the first end of the coil spring bias member, to help retain the coil spring in place with respect to thehousing structure144. The first and second ends of the coilspring bias member155 may be secured to thehousing structure144 andneedle carriage146, respectively, by any suitable connection structure including, but not limited to, adhesive, straps, thermal coupling, or the like.

The coilspring bias member155 is configured to be in a compressed state, when theneedle carriage146 is in the retracted position (shown inFIG. 7), and an expanded state, when theneedle carriage146 is in the extended position (shown inFIG. 8). When in the compressed state shown inFIG. 7, the coilspring bias member155 imparts a bias force on theneedle carriage146, in the direction ofarrow158. Theneedle carriage146 may be held in the retracted position user (or other user) to selectively activate the needle inserter device by releasing the needle carriage and allowing the force of thebias member155 to move theneedle carriage146 in the direction of thearrow158. In the embodiment ofFIG. 7, theactuation member159 includes a rigid lever (or other structural member) that engages astop surface161 on theneedle carriage146 and is moveable in the direction of arrow163 (by actuation of a manual lever, button or other operator, not shown) to a position in which the lever does not engage thestop surface161, to allow theneedle carriage146 to move in the direction ofarrow158, under the force of thefirst bias member155. While a manual lever, button or other operator may be employed to initiate movement of theactuation member159, other embodiments may employ an automatic activation mechanism for moving the actuation member159 (or otherwise release theneedle carriage146 for movement in the direction of arrow158), such as, but not limited to, a mechanism that moves theactuation member159 or otherwise releases the needle carriage for movement, in response to an expiration of a period of time from a sensor detecting the application of the delivery device (or components thereof) on the skin of user (or in another suitable location of operation). In yet other embodiments, suitable electronics may be included in the delivery device to allow the actuation member159 (or other suitable mechanism for releasing theneedle carriage146 for movement in the direction of arrow158) to be activated by a signal from theCCD16 or thecomputer18, for example, through a programmed timing sequence or in response to an input from a user of theCCD16 orcomputer18.

The embodiment ofFIGS. 7 and 8 includes asecond bias member156, for providing a bias force on theneedle142, in the direction opposite to the direction ofarrow158. In the example embodiment ofFIGS. 7 and 8, thesecond bias member156 includes a coil spring, which is configured to be compressed to the state shown inFIG. 7 and expand under its own spring force to the state shown inFIG. 8. The coilspring bias member156 may be made of any suitable spring material, including, but not limited to, metal, plastic, composite material or the like, and is arranged around and generally coaxially with the longitudinal axis A of theneedle shaft172 and thecannula148.

The upper surface (relative to the orientation direction ofFIGS. 7 and 8) of theneedle carriage146 may include an annular groove for receiving a portion of the one end of the coilspring bias member156, to help retain the coil spring in place with respect to theneedle carriage146. Similarly, anannular groove180 may be provided on the lower surface (relative to the orientation direction inFIGS. 7 and 8) of theneedle head170, for receiving a portion of the other end of the coilspring bias member156, to help retain the coil spring in place with respect to theneedle head170. The ends of the coilspring bias member156 may be secured to theneedle head170 andneedle carriage146, respectively, by any suitable connection structure including, but not limited to, adhesive, straps, thermal coupling, or the like.

In the retracted position shown inFIG. 7, the coil springsecond bias member156 is held in a compressed state, by at least onepivotal pawl160. InFIG. 7, onepawl160 is shown. However, in other embodiments, two or more pivotal pawls, similar topawl160, may be located around the perimeter of theneedle carriage146. Thepawl160 includes a rigid lever mounted to theneedle carriage146 by apivotal connection165, for pivotal motion in the directions of thedouble arrow167. InFIG. 7, thepawl160 is in a locking position, at which a surface of the pawl abuts the upper surface (relative to the orientation inFIG. 7) of theneedle head170. In the locking position, thepawl160 retains theneedle142, against the force of the coilspring bias member156, to maintain the coilspring bias member156 in its compressed state.

On the other hand, as theneedle carriage146 andcannula148 are moved to the extended position, thepawl160 engages anengagement surface166 on thehousing structure144 and pivots to disengage from theneedle head170 and release theneedle142, as shown inFIG. 8. The surface of thepawl160 that engages theengagement surface166 may be provided with an angle surface (having an angle or curvature relative to the longitudinal axis A direction) and theengagement surface166 may be angled in a corresponding direction, to enhance pivotal motion of thepawl160, as the needle carriage is moved into an extended position.

Upon thepawl160 being pivoted to release theneedle142, the bias force of the coil springsecond bias member156 causes theneedle142 to be returned to the retracted position, leaving theneedle carriage146 andcannula148 in the extended position, as shown inFIG. 8. When theneedle142 is returned to the retracted position, theseptum152 re-seals itself and thecannula148 is arranged in fluid flow communication with the reservoir (not shown), through thefluid flow passages178 and184, in a manner similar to the manner in which cannula48 is arranged in fluid flow communication with thereservoir28, throughpassages78 and84 inFIG. 4.

In operation, with theneedle142,needle carriage146 andcannula148 in the retracted position (as shown inFIG. 7), thehousing structure144 is secured to a user's skin, for example, in a manner similar to that described above with respect to securing thedisposable housing portion20 to a user's skin. The patient-user (or other user) may activate the needle inserter device by moving theactivation lever159 from thestop surface161 of the needle carriage, to release the needle carriage. Upon releasing theneedle carriage146, the force of the coil springfirst bias member155 abruptly moves theneedle carriage146 downward (relative to the orientation inFIG. 7) in the direction ofarrow158, toward the extended position (i.e., toward the position shown inFIG. 8). As theneedle carriage146 is abruptly moved in the direction ofarrow158, thepawl160 that abuts theneedle head170 causes theneedle142 to abruptly move downward (relative to the orientation inFIG. 7) in the direction ofarrow158, with theneedle carriage146. In further embodiments, thebias member155 and/or theneedle carriage146 may include suitable motion damping structure or the like for causing theneedle142 to move slowly into a patient-user's skin, to minimize traumatic effects on the patient-user, upon releasing theneedle carriage146.

As theneedle carriage146 nears the extended position (shown inFIG. 8), a surface of thepawl160 contacts theengagement surface166. Further movement of theneedle carriage146 toward the extended position causes thepawl160 to pivot about itspivot axis165, to disengage theneedle head170. When thepawl160 is pivoted out of engagement with theneedle head170, the bias force of the coil springsecond bias member156 returns theneedle142 to its retracted position, leaving theneedle carriage146 andcannula148 in the extended position, as shown inFIG. 8. As theneedle142 retracts, theseptum152 reseals itself.

As a result, thecannula148 will be inserted into the patient-user and also will be connected in fluid flow communication with a reservoir (not shown). Thereafter, infusion medium within the reservoir may be selectively delivered to the patient-user, through thecannula148 andfluid flow passages178 and184, by operation of a drive mechanism on the reservoir, as described above. The patient-user (or other user) may readily activate the needle inserter device by simple operation of the operator that controls movement of theactuation lever159.

While the embodiment inFIGS. 7 and 8 employs apivotal pawl160, other embodiments may employ other suitable catch mechanisms, including, but not limited to, a rotary pawl, a flexible pawl, an electrically actuated solenoid or the like, for selectively retaining theneedle142 with theneedle carriage146 and selectively releasing theneedle142 from the needle carriage upon the needle carriage being moved toward or into its extended position.

In the embodiment ofFIGS. 4-6, an external plunger device141 is employed to impart a force on theneedle42, to move the needle, theneedle carriage46 and thecannula48 from a retracted position to an extended position. In the embodiment ofFIGS. 7 and 8, a bias member, such as a coil spring, imparts a force on theneedle carriage146, to move theneedle carriage146,needle142 andcannula148 to an extended position. In further embodiments, a rotary drive mechanism may be employed for selectively moving the needle, needle carriage and cannula toward and into an extended position.

For example, an embodiment of a rotary drivableneedle inserter device212 is shown inFIGS. 9 and 10. Theneedle inserter device212 may include astructure213 that includes aneedle242, needle carriage, cannula, a first septum, a bias member and a second septum (or a flexible tubing), similar to theneedle42,carriage46,cannula48,first septum52, coilspring bias member56 and second septum54 (or flexible tubing) ofFIGS. 4-6. Alternatively, thestructure213 may include aneedle242, needle carriage, cannula, first and second septa and a bias member, similar to theneedle142,carriage146,cannula148,septa152 and154 and coilspring bias member156 ofFIGS. 7 and 8. While not shown inFIGS. 9 and 10, theneedle inserter device212 may be supported within a housing having a fluid flow path, reservoir connector and reservoir, similar to thefluid flow path84,reservoir connector86 andreservoir28 shown inFIG. 4. Accordingly, theneedle inserter device212 operates in a manner similar to the manner of operation of theneedle inserter devices12 and112, described above. However, actuation of theneedle inserter device212 is carried out by the rotary motion of arotatable cam member250.

With reference toFIGS. 9 and 10, therotatable cam member250 includes a rotary disk-shaped member having a central axis, along the axial direction A₁, which may be substantially parallel to the axis A of theneedle242. The disk shapedcam member250 may be made of any suitably rigid material, including, but not limited to metal, plastic, ceramic, composite material or the like. The disk shapedcam member250 has a width that varies across its diameter, as shown inFIGS. 9 and 10, so as to be thinner on one side of the central axis A₁than on the other side of the central axis A₁. Accordingly, the disk-shapedcam member250 provides a rotatable wedge, which functions to move theneedle242 from a retracted position (shown inFIG. 9) to an extended position (shown inFIG. 10), as the disk shapedcam member250 rotates from the position shown inFIG. 9 to the position shown inFIG. 10.

The rotary disk shapedcam member250 is supported for rotation about the axis A₁, on arotary shaft251. Therotary shaft251 is operatively coupled, through suitable linkage structure (not shown), such as gears, belts, drive shafts or the like, to a drive device (not shown), for rotation about the axis A₁. The drive device and linkage structures (not shown), may include any suitable drive device and linkage structures for providing selective rotational motion to theshaft251. For example, an electronic motor or other drive device described herein may be employed. In a further embodiment, therotary shaft251 may be operatively coupled to a wound spring (or windable spring), to provide rotary drive force to theshaft251, instead of an electronic motor. Further examples of drive device and linkage structures that selectively drive a rotatable shaft are described, for example, in U.S. patent application Ser. No. 11/211,095, filed Aug. 23, 2005, U.S. Patent Application No. 60/839,822, filed Aug. 23, 2006, and U.S. Patent Application No. 60/839,832, filed Aug. 23, 2006, each of which is incorporated herein by reference.

In the retracted position of the needle242 (shown inFIG. 9), the disk-shapedcam member250 may be arranged to abut (or be adjacent, but spaced from) the upper surface (relative to the orientation ofFIG. 9) of thehead270 of the needle252. In operation, therotary cam member250 is driven in a rotational motion about the axis A₁by selective operation of a rotary drive device. A button, switch, or other operator (not shown) may be operatively connected to the drive device, a power source therefore or the like, to allow a user to selectively activate the drive device, in a manner well known in the art.

As therotary cam member250 rotates from the position shown inFIG. 9, the relatively wide portion of the disk-shapedcam member250 is rotated around to abut thehead270 of the needle252 and pushes the needle252 in the direction ofarrow258, into the extended position, as shown inFIG. 10. As described above with respect to the embodiments ofFIGS. 4-8, a needle carriage and cannula may be moved, with the movement of the needle252, in the direction ofarrow258, to an extended position. Once theneedle242, needle carriage and cannula are moved into the extended position (FIG. 10), further rotation of the disk-shapedcam member250 causes the relatively thin portion of thecam member250 to rotate around into engagement with thehead270 of the needle252, allowing a bias member256 (such as a coil spring, or the like) to return theneedle242 to the retracted position (shown inFIG. 9), while the needle carriage and cannula may remain in the extended position, as described above with respect to the embodiments ofFIGS. 4-8. In the embodiment ofFIGS. 9 and 10, therotary cam member250 may be controlled to rotate in a relatively fast, abrupt motion from the position inFIG. 9 to the position inFIG. 10, to move the needle252 relatively abruptly through the patient-user's s skin, to minimize traumatic effects on the patient-user. Alternatively, therotary cam member250 may be controlled to rotate in a relatively slow motion, to move the needle252 relatively slowly through the patient-user's skin, to minimize traumatic effects on other patient-users. The speed of rotation of therotary cam member250 may be controlled by controlling the speed of the drive device, and/or by providing speed reduction gearing or the like in the linkage structure that couples the drive device to therotary cam member250.

A further embodiment of aneedle inserter device312 capable of self activation and retraction is described with reference toFIGS. 11-13. Theneedle inserter device312 includes a moveable needle-342, a needle carriage, a cannula, a first septum, a bias member, and a further needle and a second septum (or flexible tubing), similar to theneedle42,carriage46,cannula48,first septum52, coilspring bias member56 andfurther needle50 and second septum54 (or flexible tubing) ofFIGS. 4-6. Alternatively,needle inserter device312 may include aneedle342, needle carriage, a cannula, a first septum and a further needle and second septum (or a flexible tubing), similar to theneedle142,carriage146, acannula148,first septum152, coilspring bias member156 andfurther needle150 and second septum154 (or flexible tubing) ofFIGS. 7 and 8. While not shown inFIGS. 11-13, theneedle actuator312 may be supported within a housing having a fluid flow path, reservoir connector and reservoir, similar to thehousing structure44,fluid flow path84,reservoir connector86 andreservoir28 shown inFIG. 4. Accordingly, theneedle actuator312 operates in a manner similar to the manner of operation of theneedle inserter devices12 and112, described above. However, actuation of theneedle inserter device312 is carried out by afiring spring mechanism350.

Thefiring spring mechanism350 includes a spring having acoil portion351 and twoarm portions352 and353, respectively, in accordance with common spring configurations of the type used in traditional mouse-trap structures, or the like. The firing spring mechanism may be composed of any suitable spring material, including, but not limited to metal, plastic, composite material, or the like.

One of thearms352 of thefiring spring mechanism350 may be connected in a fixed relation relative to a housing (such as thehousing44 or144 described above). Thesecond arm353 is biased, by the force of thecoil portion351 of thespring mechanism350, in the direction of thearrow354. Aactuator lever355 is arranged to abut thesecond arm353, to hold it in place against the bias force of thecoil portion351. Theactuator lever355 is moveable, in response to the operation of a manual button, lever or other operator accessible to the patient-user (or other user), in the direction of arrow356 (or other suitable direction, e.g., into or out of the plane of the page ofFIG. 11), to selectively disengage thespring arm353. Upon theactuator lever355 disengaging thespring arm353, thespring arm353 is caused to abruptly move in the direction ofarrow354, by the force of thecoil portion351.

As thespring arm353 is moved in the direction ofarrow354, thespring arm353 initially contacts thehead370 of theneedle342, as shown in broken lines inFIG. 11. As thespring arm353 continues to move in the direction ofarrow354, thespring arm353 pushes downward (relative to the orientation direction ofFIG. 11) on theneedle head370, in the direction ofarrow357, to cause the needle342 (and the needle carriage and cannula) to move into an extended position. In the extended position, the cannula is connected in fluid flow communication with a reservoir, for example, in a manner similar to that described above with respect to the connection of thecannula48 with thereservoir28, through thefluid flow passages78 and84, inFIG. 4. While thespring arm353 may be allowed to move in the direction of arrow354 (upon the actuator lever disengaging the spring arm353) in an abrupt motion to minimize trauma to certain patient-users, in further embodiments, a motion damping mechanism may be coupled to thespring arm353 and/or theneedle342, to cause theneedle342 to move slowly in the direction of arrow354 (when actuated), to minimize traumatic effects to other patient-user.

Upon engaging theneedle head370 and moving theneedle342 in the direction of thearrow357, thespring arm353 continues to move in the direction ofarrow354 and engages apivotal lever359. Thepivotal lever359 may include a suitably rigid structure that is mounted for pivotal motion about apivot axis361 and includes astop surface363 arranged to engage the upper surface (in the orientation ofFIG. 11) of theneedle head370, to hold the needle head in a partially extended position (as shown inFIG. 11) against the force of areturn spring365.

Thereturn spring365 may include a coil spring or other suitable bias mechanism, for biasing theneedle342 in the direction opposite to the direction ofarrow357. In the embodiment ofFIG. 11, thereturn spring365 is disposed around and generally coaxial with the shaft of theneedle342, and has one end that abuts the lower surface (relative to the orientation ofFIG. 11) of theneedle head370. A second end of thereturn spring365 abuts an upper surface (relative to the orientation ofFIG. 11) of apositioning channel structure346. The positioning channel structure may include a portion of thehousing structure44 described above, or a further structure (made of suitably rigid material, such as, but not limited to, plastic, metal, ceramic, composite material, or the like) located within thehousing structure44 described above.

Upon engaging thepivotal lever359, further movement of thespring arm353 in the direction of thearrow354, by the force of thecoil portion351, causes thespring arm353 to pivotally move thepivotal lever359 to a position at which thestop surface363 of thelever359 is disengaged from theneedle head370, as shown inFIGS. 12 and 13. When thelever359 pivots to disengage theneedle head370, thecoil spring365 is allowed to expand under its own spring force, to move theneedle342 to a retracted position, as shown inFIGS. 12 and 13.

Accordingly, as thespring arm353 moves in the direction of thearrow354, from the position shown inFIG. 11 to the position shown inFIGS. 12 and 13, thespring arm353 engages theneedle head370 and forces theneedle342 downward (relative to the orientation ofFIG. 11) toward an extended position, whereupon the cannula is inserted through a patient-user's skin and is locked into place, in fluid flow communication with a reservoir. Thespring arm353 continues its motion in the direction ofarrow354, to engage thepivotal lever359 and pivotally move thepivotal lever359 out of engagement with theneedle head370. Upon disengagement of thepivotal lever359 with theneedle head370, thespring365 moves the needle to its retracted position, leaving the cannula in place, extending through the patient-user's skin. The spring tension of thespring365 may be selected so as to provide a relatively abrupt motion of the needle to its retracted position, to minimize discomfort to the patient-user. In further embodiments, a motion reduction mechanism may be coupled to the spring, orneedle342 to cause theneedle342 to move slowly through the patient-user's skin, to minimize discomfort to other patent-users.

While various embodiments described above employ bias members in the form of coil springs, other embodiments may employ other types of bias members, suitable to provide a sufficient bias force in the directions described herein. For example, other spring arrangements may be employed to provide a bias force for inserting a moveable needle and cannula into a patient-user and/or a bias force for removing the needle, while leaving the cannula in place. An example embodiment of aneedle inserter device412 that employs a single leaf type spring to provide both bias forces is shown inFIGS. 14-16.

Similar to embodiments described above, theneedle inserter device412 ofFIGS. 14-16 includes amoveable needle442 that is moveable relative to ahousing structure444. Similar to the above embodiments, themoveable needle442 may be extended through a central passage in aneedle carriage446 and through a cannula448 (as shown inFIGS. 14 and 15), but also may be withdrawn from at least a portion of the cannula448 (as shown inFIG. 16). Thehousing structure444 may be similar to thehousing structure44 or144 described above. Thecarriage446 may be similar to thecarriage46 or146 described above, including a further hollow needle and fluid flow passage (such as described above with respect to thefurther needle50 andfluid flow path78 ofFIG. 4) for piercing a septum and coupling in fluid flow communication with a fluid flow path in or supported by the housing structure444 (such as described above with respect to theseptum54 andfluid flow path84 ofFIG. 4).

Theneedle carriage446 is supported for motion in the direction ofarrow458 and may be guided by rails, ribs, walls or otherstructural features450 of or in thehousing444, provided along that direction of motion. InFIG. 14, theneedle inserter device412 is shown in a ready state, in which theneedle carriage446,needle442 andcannula448 are supported in a retracted position and ready to be activated. InFIG. 15, theneedle inserter device412 is shown in an insert state, in which theneedle carriage446,needle442 andcannula448 have been moved to an extended position where theneedle442 andcannula448 may pierce the skin of a patient-user on whom thehousing444 is secured. InFIG. 16, theneedle inserter device412 is shown in a needle retract state, in which theneedle442 has been retracted from the patient-user and at least a portion of thecannula448.

Theneedle inserter device412 has a bias member, such asleaf spring456, to provide a bias force for moving theneedle442,needle carriage446 andcannula448 from the ready state (retracted positions) ofFIG. 14, to the insert state (extended position) ofFIG. 15. The leafspring bias member456 also provides a bias force for moving theneedle442 from the insert state (extended position) ofFIG. 15 to the needle retract state ofFIG. 16.

In particular, theleaf spring456 is secured at oneend portion457 to ananchor structure459, and asecond end portion461 secured to thehead470 of theneedle442. Theleaf spring456 has a natural tendency to be relatively straight, between the twoend portions457 and461. When theneedle442,needle carriage446 andcannula448 are in the ready state (retracted position) ofFIG. 14, theleaf spring456 is arched or bowed against its natural spring force, to impart a bias force on theneedle442 in the direction of thearrow458.

Theneedle442,needle carriage446 andcannula448 may be held in place in the ready state (retracted position) ofFIG. 14 by any suitable trigger mechanism. In one embodiment, the trigger mechanism may include a moveable pin or lever463 that extends through anopening465 in thehousing structure444 and has oneend467 located inside of thehousing structure444, for engaging theend portion461 of theleaf spring456. The pin orlever463 and or theend portion461 of theleaf spring456 may include a catch mechanism, latch, hook or other configuration that allows thepin463 to hold theend portion461 of theleaf spring456 in the arched or bowed state ofFIG. 14, against its natural spring force, yet allow the pin orlever463 to be selectively, manually moved to disengage theend portion461 of theleaf spring456 and release theleaf spring456. Once the pin or lever463 releases theleaf spring456, the natural spring force of theleaf spring456 moves theneedle442,needle carriage446 andcannula448 in the direction ofarrow458, to the insertion state ofFIG. 15. The pin orlever463 has asecond end469, located outside of thehousing structure444, for manual activation by a patient-user (or other user).

As described above, by manually activating the pin orlever463 to disengage theend portion461 of theleaf spring456, theleaf spring456 moves theneedle442,needle carriage446 andcannula448 in the direction ofarrow458, to the insertion state ofFIG. 15. More specifically, theend portion461 of theleaf spring456 pushes downward (in the orientation shown inFIG. 14), in the direction ofarrow458, on thehead470 of theneedle442. The force of theleaf spring456 is conveyed by theneedle head470 to theneedle carriage446 andcannula448, to drive those components to the insertion state (extended position) shown inFIG. 15. As theneedle442 is moved to the insertion state (extended position), the sharp end of the needle that protrudes from the end of thecannula448 pierces the patient-user's skin and inserts thecannula448 into the patient-user. At the same time, thecannula448 may be connected in fluid flow communication with a reservoir (for example, in the manner described above with respect toFIGS. 4-8) Alternatively, a reservoir (not shown inFIGS. 14-17) may be connected in fluid flow communication with the central passage of theneedle carriage446, through aflexible conduit471 that moves and/or flexes with the movement of theneedle carriage446. Also, other embodiments described above with respect toFIGS. 4-13 may include a flexible conduit (similar to conduit471) connected to the central passage of theneedle carriage446 and in fluid flow communication with a reservoir (e.g., instead of the furtherhollow needle50,fluid channels78 and84 andseptum54 described above with respect toFIGS. 4-6).

When theneedle carriage446 is moved to the insertion state (extended position) ofFIG. 15, theneedle carriage446 is locked into position by a lockingpawl460. In particular, a lockingpawl460 extends into the path of motion of theneedle carriage446 and is engaged by theneedle carriage446, as theneedle carriage446 is moved to the insertion state (extended position) ofFIG. 15. Thepawl460 is supported on or in thehousing structure444 and may be similar in structure and function to thepawl60 described with respect toFIGS. 4-6.

Thepawl460 may bend or pivot downward (relative to the orientation ofFIGS. 14-16) as at least a portion of theneedle carriage446 passes thepawl460, until astop surface462 on theneedle carriage446 moves past thepawl460. Upon thestop surface462 moving past thepawl460, thepawl460 is allowed to flex or pivot back toward its un-flexed or non-pivoted position and engages thestop surface462. With thepawl460 engaging thestop surface462, theneedle carriage446 is inhibited from moving upward (relative to the orientation ofFIGS. 14-16) in the direction opposite to the direction ofarrow458. In that manner, theneedle carriage446 andcannula448 may be held in place, in the insert state (extended orientation) ofFIG. 15.

The position of theneedle head470, when theneedle carriage446 is in the insert state (extended position) ofFIG. 15 is below (in the orientation ofFIG. 15) the position of theend portion461 of thespring456 in its unflexed, natural or straight orientation (shown in broken lines inFIG. 15 and in solid lines inFIG. 16), such that theleaf spring456 is arched or bowed against its natural spring force, when in the insert state (extended orientation) ofFIG. 15. Accordingly, upon thespring456 moving theneedle442,needle carriage446 andcannula448 to the insert state (extended position) ofFIG. 15, the leaf spring automatically returns to its unflexed, straight state and, in doing so, imparts a force on theneedle head470 to move theneedle442 in the direction opposite to the direction ofarrow458, to the needle retract state shown inFIG. 16. As theneedle442 is moved in the direction opposite to the direction of thearrow458, theneedle442 is withdrawn from the patient-user and from at least a portion of thecannula448, leaving thecannula448 in place, in the patient-user and ready to deliver the infusion medium to the patient-user.

The spring tension of theleaf spring456 may be selected so as to provide a relatively abrupt motion of theneedle442,needle carriage446 andcannula448 from the ready state (retracted position) ofFIG. 14 to the insert state (extended position) ofFIG. 15 and to also provide a relatively abrupt motion of theneedle442 from the insert state (extended position) ofFIG. 15 to the needle retract state ofFIG. 16. Also, the motion of theneedle442 may be relatively smooth and steady, by the action of the leaf spring and theguide structure450. In that manner, trauma on the patient-user may be minimized. Alternatively, the spring tension may be selected and/or a motion damping mechanism may be provided to cause theneedle442 to move slowly toward the extended position (FIG. 15), to minimize trauma to other patients-users. Other embodiments described above with respect toFIGS. 4-13 may include similar guide structure for guiding the needle carriage in its motion.

A further embodiment of aneedle inserter device512 is described with respect toFIGS. 17-19. The needle inserter device512 (shown inFIG. 17) includes ahousing portion544, which may be similar in certain manners to thehousing portion44 described above with respect toFIGS. 4-6. However, thehousing portion544 includes achannel550 that extends through skin-facingsurface545 of the housing portion base to a patient-user's skin, when thehousing portion544 is secured to a patient-user's skin as described above with respect tohousing portion44.

Thechannel550 includes acannula passage552 that opens to the patient-user's skin, when thehousing portion544 is secured to a patient-user. Thechannel550 also includes asuitable locking structure554, for engaging a surface of a cannula nest and holding the cannula nest in place, as described below. The lockingstructure554 may include, for example, one or more flexible or pivotal tabs arranged around the longitudinal axis A₂of thechannel550 andpassage552, where each tab has alip556 that extends inward toward the axis A₂. Alternatively, other suitable locking structures, including, but not limited to, frictional fitted structures or the like, may be employed.

Theneedle inserter device512 operates with an external needle injector560 (shown inFIG. 19). Theneedle injector560 operates to insert aneedle542 andcannula548 into a patient-user's skin, through thechannel550 and then remove theneedle542, while leaving thecannula548 in place. With thecannula548 in the patient-user and extending at least partially into thechannel550, the cannula may be connected in fluid flow communication with a reservoir528, as described below. Theneedle542,cannula548 and reservoir528 may be similar in structure and function in certain manners to theneedle42,cannula48 andreservoir28, described above.

Theneedle injector560 has atubular body562 with a hollow interior containing acoil spring564 and aplunger head566. Ashaft568 is fixed to and extends from the plunger head, along the longitudinal axis A₃of thetubular body562, and through an opening in anend wall570 of thetubular body562, to a location outside of thetubular body562. Ahandle572 may be provided on the outside end of theshaft568. Thecoil spring564 is arranged around the longitudinal axis A₃of thetubular body562 and has one end abutting theend wall570 of thetubular body562 and an opposite end abutting theplunger head566.

Theneedle542 is attached to theplunger head566, opposite to the side of the plunger head that abuts thecoil spring564. Theneedle542 extends along the direction of the longitudinal axis A₃of thetubular body562 and has a sharp end opposite to the end connected to theplunger head566.

Thecannula nest574 may include a generally tubular body having a central channel576, afirst end578 and a second end579. Thefirst end578 has an end surface configured to engage thelip556 of each lockingstructure tab554, as described below. The second end579 of thecannula nest574 is formed integral with or otherwise connected in a fixed relation to thecannula548, with the cannula in fluid flow communication with one end of the central channel576 of thecannula nest574. Asealable septum580 is secured to thecannula nest574, over and sealing the end of the central channel576 opposite to the end that is connected to thecannula548.

To operate, thehousing structure544 is secured to a patient-user's skin, with thesurface545 facing the patient-user's skin. Acannula nest574 andcannula548 assembly is attached to theneedle542 of theinjector560, by inserting theneedle542 through theseptum580 of the cannula nest and through the central channel576 andcannula548. Then theneedle injector560 is positioned adjacent thechannel550, with the axis A₃of theinjector body562 generally aligned with the axis A₂of thechannel550 as shown inFIG. 19. The patient-user (or other user) may pull back on thehandle572 of the injector, to cause theplunger head566 to move toward theend wall570 of theinjector body562 and compress thecoil spring564 between theplunger head566 and theend wall570.

The patient-user (or other user) may then release the handle and allow the coil spring to force theplunger head566 in the direction away from theend wall570 and, at the same time, push theneedle542 andcannula548 through thechannel550 and into the patient-user's skin. The spring tension of thespring564 is selected such that the motion of theplunger head566 pushes thecannula nest574 through the flexible orpivotal tabs554 to a position at which theend surface578 abuts against thelip556 of eachtab554. As thecannula nest574 is pushed through thetabs554, thetabs554 flex or pivot to allow the relatively wide portion of the cannula nest body to pass, before the tabs are allowed to flex or pivot back toward an unflexed or non-pivoted state at which thetab lips556 engage theend surface578 of the cannula nest and hold the cannula nest in place.

Upon thecannula nest574 being locked into place by thetabs554, thecoil spring564 has extended beyond its natural, un-tensioned length, as a result of the momentum of the plunger head motion. Accordingly, thecoil spring564 imparts a force on theplunger head566 andneedle542, to cause the plunger head to move back toward theend wall570 and withdraw theneedle542 from thecannula nest574 andcannula548. Alternatively, or in addition, theneedle injector560 may be mannualy moved in the axial direction A₃away from thechannel550, to pull theneedle542 out of thecannula548 andcannula nest574. As theneedle542 withdraws from theseptum580 in thecannula nest574, theseptum580 reseals itself, leaving the cannula in place in the patient-user's skin and in fluid flow communication with the interior of thechannel550.

Thereafter, the reservoir528 may be connected in fluid flow communication with thechannel550, to allow fluid delivery from the reservoir528, to the patient-user, though thecannula548. The reservoir528 may be supported by thehousing structure544 and may be operatively coupled to a drive device for driving the infusion medium from the reservoir528 into aconduit530. Theconduit530 may include any suitable tubing structure or passage having a fluid flow channel connected in fluid flow communication with the interior of the reservoir528, for conveying fluid from the reservoir528. For example, theconduit530 may include a flexible, plastic tubing.

Theconduit530 is also provided in fluid flow communication with ahollow needle532. Thehollow needle532 and a portion of theconduit530 may be supported on acover member534 that is pivotally connected to thehousing structure544. Thecover member534 may be pivotal, relative to thehousing structure544, to a first position at which thechannel550 is exposed for operation with aneedle injector560, as described above, and to a second position to cover thechannel550. Thehollow needle532 may be positioned on thecover member534 at a location at which the sharp end of the needle extends into thechannel544, when thecover member534 is pivoted to the second position over and covering thechannel550. Accordingly, a patient-user (or other user) may cause thehollow needle532 to pierce and pass through theseptum580 on a cannula nest structure located within thechannel550, to connect the reservoir528 in fluid flow communication with the cannula nest structure andcannula548.

A further embodiment of aneedle inserter device612 is described with respect toFIGS. 20-23. The needle inserter device612 (shown inFIG. 20) includes abase portion644, which may be arranged within a disposable housing portion20 (shown inFIGS. 2 and 3). In other embodiments, theneedle inserter device612 may be located in thedurable housing portion22 or in an injection site module connected to thedisposable housing portion20 or thedurable housing portion22, as described herein. Alternatively, theneedle inserter device612 may be included in other systems that operate by inserting a needle into a subject or object.

The base644 may include a generally rigid support structure having an aperture or opening, through which a needle and a cannula may extend, as shown inFIGS. 21 and 22. The base64 supports a pair ofpivotal arms646 and648, for pivotal motion about a respective pair ofpivot axis646aand648a. A suitable hinge or pivot axle may be provided to connect thepivotal arms646 and648 to thebase644. Thebase644 and the pivotal arms may be made of any suitably rigid materials, including, but not limited to metal, plastic, ceramic, composite material or the like. While the embodiment inFIGS. 20-23 includes twopivotal arms646 and648, other embodiments may include no more than one pivotal arm or more than two pivotal arms connected to the base644 at respective pivot axes.

Thebase644 supports a pair ofcoil springs650 and652. Thecoil spring650 is arranged to function as an insertion spring, while thecoil spring652 is arranged to function as a retraction spring. Eachcoil spring650,652 has a coil wire member that is spirally wound around an open coil interior. The open coil interiors of the coil springs650 and652 are arranged coaxially and are aligned with the needle or cannula opening in thebase644. A needle654 is supported by theinsertion spring650. The needle654 includes aneedle shaft655 and aneedle head656. Theinsertion spring650 has one end that abuts theneedle head656 and a second end that abuts thebase644. A hollow cannula (not shown inFIGS. 20-23) may be arranged around theshaft655 of the needle.

Theretraction spring652 has one end that abuts aflange member658 and a second end that abuts thebase644. In a starting position, theretraction spring652 is arranged in a compressed state, between theflange member658 and thebase644, as shown inFIG. 20. Thepivotal arms646,648 may include a stop surface, such as projectingsurfaces646band648b, for engaging theflange member658, to hold theflange member658 in place against the force of thecompressed retraction spring652, when thepivotal arms646 and648 are in a locking position as shown inFIG. 20.

While thepivotal arms646 and648 are in the locking position to hold theflange member658 andretraction spring652 in place, a manual (or automated) force may be applied to the needle head656 (in the direction of arrow659), to move the needle654 against the force of theinsertion spring650. By applying a force on theneedle head656 in the direction ofarrow658, the needle654 and a cannula on theneedle shaft655 may be moved toward an insertion position as shown inFIG. 22, at which theinsertion spring650 is compressed between theneedle head656 and thebase644. As the needle654 and cannula move from the position shown inFIG. 20 toward the position shown inFIG. 22, the needle654 first reaches a partially extended position shown inFIG. 21.

In the partially extended position shown inFIG. 21, the sharp end of theneedle656 and at least a portion of the cannula around theneedle shaft655 are extended through the opening in thebase644, to the position shown inFIG. 21. Further force on theneedle head656 causes the needle and cannula to continue to move in the direction ofarrow658, to the fully extended position shown inFIG. 22. The cannula (not shown inFIGS. 21-23) may be supported on a carriage, similar to thecarriage46 or146 described above and may engage a locking mechanism, such as but not limited to,pawls60 or160 described above, when in the fully extended position ofFIG. 22. In addition, the cannula (not shown inFIGS. 21-23) may be connected in fluid flow communication with a reservoir, when in the fully extended position, for example, but not limited to, the fluid flow connection structure described above with respect to thecannula48 or148 and thereservoir28. To simplify the present disclosure, reference is made to the description of the cannula locking structure and fluid flow connection to thereservoir28 of the embodiments inFIGS. 4-8. By supporting the base644 at an injection site (either in thedisposable housing portion20, thedurable housing portion22 or an injection site module), thebase644 may be arranged adjacent a patient-user's skin (for example, when thedisposable housing portion20, thedurable housing portion22 or the injection site module is arranged adjacent the patient-user's skin, as described above), to allow the sharp end of the needle654 to pierce the patient-user's skin and to allow the cannula around the needle shaft to be inserted at least partially into the patient-user's skin, when the needle is in the fully extended position ofFIG. 22.

Once the needle654 and cannula are in the partially extended position ofFIG. 21, further movement of the needle654 in the direction ofarrow658 to the position shown inFIG. 22 causes theneedle head656 to engage thepivotal arms646 and648 and pivot thearms646 and648 to an unlocked position as shown inFIG. 22. Thepivotal arms646 and648 may have angledsurfaces646cand648c, respectively, for engagingneedle head656, to more efficiently transfer the linear motion of theneedle head656 to pivotal motion of thearms646 and648, as theneedle head656 engages and moves along theangled surfaces656cand648cin the direction ofarrow658.

In the unlocked position of thearms646 and648, theflange658 is no longer held in place by thearms646 and648 against the force of theretraction spring652. Accordingly, when thearms646 and648 are moved into the unlocked position, theretraction spring652 forces theflange member658 against theneedle head656 and forces the needle654 to move in the direction opposite to the direction ofarrow658, to a retracted position, as shown inFIG. 23. However, the cannula is left in place, extending into the patient-user's skin, similar to the function of thecannula48 or148 in the embodiments ofFIGS. 4-8. Accordingly, the insertion device shown inFIGS. 21-23 may be employed to insert a needle and cannula into a patient-user's skin and withdraw the needle, leaving the cannula in place.

A further embodiment of aneedle inserter device712 is described with respect toFIGS. 24-25. InFIG. 24, theneedle inserter device712 is in a retracted or starting position. InFIG. 25, theneedle inserter device712 is in an extended position. The needle inserter device712 (shown inFIG. 24) includes ahousing portion744, which may be arranged within a disposable housing portion20 (shown inFIGS. 2 and 3).

In other embodiments, theneedle inserter device712 may be located in thedurable housing portion22 or in an injection site module connected to thedisposable housing portion20 or thedurable housing portion22, as described herein. Alternatively, theneedle inserter device712 may be included in other systems that operate by inserting a needle into a subject or object. Thehousing744 may include a rigid, generally cylindrical or disc-shaped body, having a hollow, generally cylindrical interior and a longitudinal dimension along the axis A₃of the generally cylindrical shape of the body. The interior surface of thehousing744 has aspiral groove746 that starts near, but spaced from, the top of the housing744 (relative to the orientation shown inFIG. 24) and extends around the inner peripheral wall of thehousing744, to a location near the base of thehousing744. A further,linear groove748 is provided at the base end of the spiral groove and extends toward the top end of the housing (relative to the orientation shown inFIG. 24). The linear groove connects the base end of the spiral groove with the top end of thespiral groove746 and extends a short distance above the top end of thespiral groove746.

Acam member750 is located within the interior of thehousing744 and has aprojection751 that is arranged to extend into thegrooves746 and748. Thehousing744 includes anopening752 on one end (the top end in the orientation ofFIG. 24), through which thecam member750 may be operated by manual or automated force. A surface of thecam member750 may be exposed through theopening752. That exposed surface of thecam member750 may include a convex-shape, that extends into or partially through theopening752, when thecam member750 is in a retracted position, as shown inFIG. 24. Thehousing744 also includes aneedle opening754 through the base of thehousing744, through which a needle and cannula may be extended, as described below.

Thecam member750 is supported within the interior of thehousing744 by acoil spring754. Thecoil spring756 extends between thecam member750 and the base of thehousing744 and has one end secured to (or adjacent to) the base portion of thehousing744 and another end secured to thecam member750.

In the starting or retracted position ofFIG. 24, thecoil spring754 is partially unwound against its natural wound state, such that thespring746 imparts a force on thecam member750, in the winding direction of the spring. However, because theprojection751 of thecam member750 is located within thegroove748, thespring746 is held in the partially unwound state, against the natural winding force of thespring756.

From the retracted position shown inFIG. 24, a manual or automated force may be applied to thecam member750, through theopening752 in thehousing744, to force the cam member to move in the axial direction A₅, along the direction ofarrow755 and partially compress the coil spring against the natural compression force of the spring, until thecam projection751 moves along thelinear groove748, toward the base of thehousing744 to align with the top end (relative to the orientation ofFIG. 24) of thespiral groove746. Once thecam projection751 is aligned with thespiral groove746, the natural winding force of thespring756 causes thecam member750 to rotate and move toward the base of thehousing744, while thecam projection751 follows thespiral groove746, as the spring winds toward its natural, untensioned state of winding. However, as thecam member750 moves toward the base of thehousing744, thecam member750 compresses thespring756 against its natural longitudinal dimension (in the dimension from the of the axis A₃).

As thecam member750 moves toward the base of thehousing744, aneedle758 is moved through theopening754 in the base of thehousing744, to the extended position (shown inFIG. 25). Theneedle758 is secured to a surface of the cam member that faces the base, so as to move with the base from the start or retracted position of thecam member750 and needle758 (shown inFIG. 24) to the extended position of thecam member750 and needle758 (shown inFIG. 25). A cannula may be supported on the shaft of theneedle758, adjacent the sharp end of the needle.

By supporting the base of thehousing744 at an injection site (either in thedisposable housing portion20, thedurable housing portion22 or an injection site module), thehousing744 may be arranged adjacent a patient-user's skin (for example, when thedisposable housing portion20, thedurable housing portion22 or the injection site module is arranged adjacent the patient-user's skin, as described above), to allow the sharp end of theneedle758 to pierce the patient-user's skin and to allow the cannula around the needle shaft to be inserted at least partially into the patient-user's skin, when the needle is in the extended position ofFIG. 25.

Once theneedle758 and cannula are in the extended position ofFIG. 25, the cam projection751 (which had followed the spiral path of the groove746) is aligned with thelinear groove748. At that position, thespring756 is extended in the longitudinal dimension of axis A₅beyond its natural longitudinal state. Accordingly, thespring756 provides a force on thecam member750, to move thecam member750 in the axial dimension A₅, in the direction opposite to the direction ofarrow755, while theprojection751 follows thelinear groove748, to the retracted position ofFIG. 24. The cannula (not shown inFIGS. 24-25) may be supported on a carriage, similar to thecarriage46 or146 described above and may engage a locking mechanism, such as but not limited to,pawls60 or160 described above, when in the fully extended position ofFIG. 25. In addition, the cannula (not shown inFIGS. 24-25) may be connected in fluid flow communication with a reservoir, when in the fully extended position, for example, but not limited to, the fluid flow connection structure described above with respect to thecannula48 or148 and thereservoir28. To simplify the present disclosure, reference is made to the description of the cannula locking structure and fluid flow connection to thereservoir28 of the embodiments inFIGS. 4-8. Accordingly, as thecam member750 moves toward the retracted position, theneedle756 is retracted from the patient-user, but the cannula remains in the patient-user. Accordingly, the insertion device shown inFIGS. 24 and 25 may be employed to insert a needle and cannula into a patient-user's skin and withdraw the needle, leaving the cannula in place.

A further embodiment of aneedle inserter device812 is described with respect toFIGS. 26-27. InFIG. 26, theneedle inserter device812 is in a retracted or starting position. InFIG. 27, theneedle inserter device812 is in an extended position. Theneedle inserter device812 includes ahousing844 that is similar to thehousing744 described above with respect toFIGS. 24 and 25. However, thehousing844 has a needle aperture oropening846 that is off-center, relative to the axis of the generally cylindrical shape of thehousing844. Theneedle inserter812 inFIGS. 26 and 27 includes arotary disc848, supported for rotation by anaxle850, at an obtuse angle relative to the axial dimension A₄, within the interior of thehousing844. Acoil spring852 in the form of a coiled wire or ribbon is supported within thehousing844 and has one wire or ribbon end fixed with respect to thehousing844 and a second wire or ribbon end secured to and fixed with respect to an off-center location of thedisc848.

Aneedle854 is supported within thehousing844, in alignment with theneedle opening846. Theneedle854 has aneedle head856 arranged to abut a surface of thedisc848, as thedisc848 rotates about the axis A₄. In one embodiment, a coil spring (not shown inFIGS. 26 and 27) is provided between theneedle head856 and the base of thehousing844, to bias the needle in toward the retracted position ofFIG. 26. Theneedle head856 may fit within a groove or shapedchannel858 provided in thehousing844. The groove orchannel858 extends in the longitudinal direction, parallel to the axis A₄.

When thedisc848 andneedle854 are in the starting position ofFIG. 26, thecoil spring852 is partially uncoiled (or coiled) against its natural spring force. Thedisc848 may be held in the starting position by a manually operable lever or other suitable mechanism that may be release by manual operation. Once released, thecoil spring848 partially coils (or uncoils) under its own spring tension and rotates thedisc848 about the axis A₄. Because thedisc848 is supported at an angle relative to the axis A₄, rotation of thedisc848 forces theneedle head856 in the direction toward the base of thehousing844 and, thus moves theneedle854 toward the extended position shown inFIG. 27.

By supporting the base of thehousing844 at an injection site (either in thedisposable housing portion20, thedurable housing portion22 or an injection site module), thehousing844 may be arranged adjacent a patient-user's skin (for example, when thedisposable housing portion20, thedurable housing portion22 or the injection site module is arranged adjacent the patient-user's skin, as described above), to allow the sharp end of theneedle854 to pierce the patient-user's skin and to allow a cannula around the needle shaft to be inserted at least partially into the patient-user's skin, when the needle is in the extended position ofFIG. 27. The cannula (not shown inFIGS. 26-27) may be supported on a carriage, similar to thecarriage46 or146 described above and may engage a locking mechanism, such as but not limited to,pawls60 or160 described above, when in the fully extended position ofFIG. 27. In addition, the cannula (not shown inFIGS. 26-27) may be connected in fluid flow communication with a reservoir, when in the fully extended position, for example, but not limited to, the fluid flow connection structure described above with respect to thecannula48 or148 and thereservoir28. To simplify the present disclosure, reference is made to the description of the cannula locking structure and fluid flow connection to thereservoir28 of the embodiments inFIGS. 4-8.

Once thedisc848 andneedle854 are in the extended position ofFIG. 27, further rotation of thedisc848 allows theneedle854 to be retracted back toward the retracted or starting position shown inFIG. 26, while leaving the cannula in place at least partially within the patient-user's skin. Retraction of theneedle854 may be provided, for example, by the force of a coil spring or other suitable bias mechanism, as described above. Accordingly, the insertion device shown inFIGS. 26 and 27 is another example of a structure that may be employed to insert a needle and cannula into a patient-user's skin and withdraw the needle, leaving the cannula in place. Alternatively, or in addition, the needle head may be connected to, but ride within an annular groove within thedisc848 so as to be pulled back by the disc into a retracted position, as thedisc848 completes a full 360 degree rotation.

A further embodiment of aneedle inserter device912 is described with respect toFIGS. 28-31.FIGS. 28 and 29, show an external perspective view and a cross-sectional view, respectively, of theneedle inserter device912, with a needle and cannula in a retracted or starting position. InFIG. 30, theneedle inserter device912 is shown, with the needle and cannula in an extended position. InFIG. 31, theneedle inserter device912 is shown in a cross-sectional view, with the needle in a retracted position and the cannula in an extended position and connected in fluid-flow communication with a fluid conduit.

More specifically, theneedle inserter device912 includes ahousing portion944, which may be arranged within a disposable housing portion20 (shown inFIGS. 2 and 3). In other embodiments, theneedle inserter device912 may be located in thedurable housing portion22 or in an injection site module connected to thedisposable housing portion20 or thedurable housing portion22, as described herein. Alternatively, theneedle inserter device912 may be included in other systems that operate by inserting a needle into a subject or object.

Thehousing944 includes a rigid body that has aninterior channel946 with a longitudinal dimension along the axis A₄. Thehousing944 may be made of any suitably rigid material, including, but not limited to metal, plastic, ceramic, composite material or the like. Thehousing944 also has a slot-shapedopening948 that is open to theinterior channel946 and extends along at least a portion of the length of theinterior channel946, in the longitudinal dimension of the axis A₄. Ahollow needle950 is supported within thechannel946 for movement relative to thehousing944, between a retracted or start position (shown inFIGS. 28 and 29), to an extended position (shown inFIG. 30), and back to a retracted position (shown inFIG. 31). Theneedle950 may be made of any suitable material, including, but not limited to metal, plastic, ceramic, glass, composite material or the like.

Thehollow needle950 has a hollow interior and asharp end950aprovided with an opening into the hollow needle interior. Thehollow needle950 also has asecond end950bthat has another opening into the hollow needle interior. A flexible fluid-flow conduit952 is connected in fluid-flow communication with the opensecond end950bof theneedle950. Theflexible conduit952 is also connected (at another end, not shown inFIG. 29) to an infusion fluid reservoir, such as a reservoir in thedisposable housing portion20 as described above, or another suitable reservoir, to connect a source of infusion fluid to the hollow needle. Theconduit952 may be flexible, to flex and move with the motion of theneedle950, as theneedle950 moves between a retracted or start position and an extended position.

Acannula954 having acannula nest956 is supported on theneedle950, when theneedle950 is in a start position, as shown inFIG. 29. The cannula may be made of any suitable material having sufficient rigidity to operate as described herein and may have sufficient flexibility for patient-user comfort, including, but not limited to metal, plastic, ceramic, glass, composite material or the like. Thenest956 may be made of any suitably rigid material that also has sufficient flexibility to operate as described herein, including, but not limited to metal, plastic, ceramic, glass, composite material or the like. In one embodiment, thenest956 is made of a relatively flexible or soft material, such as, but not limited to a silicon, plastic or other suitable material, to provide a sealing function, as described below. Thenest956 is rigidly secured to one end of thecannula954. In further embodiments, thenest956 andcannula954 may be formed as a single, unitary member.

Thecannula954 andnest956 are initially supported on theneedle950 in the start position, with theneedle950 extending through the hollow interior of thecannula954 and with thesharp end950aof theneedle950 extending beyond one end of thecannula954, as shown inFIG. 29. Thecannula954 andnest956 move with the movement of the needle, from the initial start or retracted position ofFIG. 29, to the extended position ofFIG. 30. Thenest956 is provided with one ormore locking tabs956afor engaging and abutting one or more stop surfaces958 on thehousing944, when thecannula954 andnest956 reach the extended position ofFIG. 30. The locking tab(s)956amay be suitably flexible, to flex enough to ride over the portion of thehousing944 adjacent the stop surface(s)958 and then flex back into engagement with the stop surface(s)958. When the locking tab(s)956alock into place against the stop surface(s)958, thecannula954 and thenest956 are locked into an extended position, as shown inFIGS. 30 and 31. Once thecannula954 andnest956 are locked into place, theneedle950 may be retracted back to the retracted position, while leaving thecannula954 in the extended position, as shown inFIG. 31.

A pair ofspring members960 and962 andlever members964 and966 are provided to impart a force on theneedle950 andcannula954, in the axial dimension A₄, to move theneedle950 andcannula954 from the start position (shown inFIG. 29), in the direction ofarrow968, to the extended position (shown inFIG. 30).

As shown inFIG. 29, thelever964 is connected to theneedle950, adjacent theneedle end950band is moveable with theneedle950, between the retracted or start position (ofFIG. 29) to the extended position (ofFIG. 30) and back to a retracted position (ofFIG. 31). Thelever964 extends through theslot948 in thehousing944 and moves linearly along theslot948, as theneedle950 is moved between the retracted or start position (ofFIG. 29) to the extended position (ofFIG. 30) and back to a retracted position (ofFIG. 31).

Thespring960 is a spring wire that has a pair of ends (one end shown inFIG. 28) that are connected in a fixed relation to thehousing944. For example, each end of thespring960 may be wrapped around a grooved protrusion orear969 on thehousing944, and held in place by the natural spring force of thespring960. Thespring960 is configured to be bent against its natural spring force, into the position shown inFIG. 28, wherein aportion960aof thespring960 extends over thelever964, but is urged in the direction ofarrow968 by the natural spring force of thespring960. Theportion960aof thespring960 is initially held within a groove in thelever966. Thelever966 is supported by thehousing944 for pivotal motion in the direction ofarrow970.

Upon pivoting of thelever966 in the direction of arrow970 (for example, by application of manual or mechanical force on thelever966 in the direction of arrow970), theportion960aof thespring960 is released from the lever and abuts thelever964. Upon abutting thelever964, thespring960 imparts a force on thelever964 in the direction ofarrow968, to move theneedle950 from the retracted or start position ofFIGS. 28 and 29 to the extended position ofFIG. 30. Upon reaching the extended position ofFIG. 30, the continued motion or momentum of thespring960 causes the tip of thelever964 to break or bend away, freeing thespring960 from thelever964. Once thespring960 is freed from thelever964, the lever964 (and theneedle950 connected to the lever964) is moved back to the retracted position (as shown inFIG. 31), under the force of thespring962. In particular, thespring962 has a pair of ends that are connected in a fixed relation to thehousing944, similar to the manner described above forspring960. Acentral portion962aof thespring962 is arranged adjacent and in abutment with thelever964, to move thelever964 in the direction opposite toarrow968, from the extended position ofFIG. 30 to the retracted position ofFIG. 31.

The relative spring strengths of thesprings960 and962 are selected such that the spring force of the spring960 (for moving thelever964 from the retracted or start position ofFIG. 29 to the extended position ofFIG. 30) is sufficiently greater than the spring force of the spring962 (for moving thelever964 from the extended position ofFIG. 30 to the retracted position ofFIG. 31). Also, the material from which thelever964 is made is selected to provide the break-away or bending feature, to allow thespring960 to free itself from thelever964, when the lever reaches the extended position ofFIG. 30.

Accordingly, in operation, theneedle950,cannula954, springs960 and962 andlevers964 and966 are arranged as shown inFIGS. 28 and 29, in a retracted or start position. To activate the device, a user may manually (or mechanically) pivot thelever966 to release thespring960 and cause thespring960 to force thelever964 toward the extended position. As thelever964 moves toward the extended position, theneedle950 andcannula954 are also moved with thelever964 to the extended position ofFIG. 30. In the extended position, thecannula nest956 locks thecannula954 in place in the extended position. In addition, thespring960 frees itself from thelever964 and allows thespring962 to move thelever964 back to the retracted position. As thelever964 moves back to the retracted position, theneedle950 is also moved back to the retracted position, as shown inFIG. 31. In the retracted position, theneedle950 provides a hollow conduit, connecting theconduit952 in fluid-flow communication with thecannula954. Accordingly, thecannula954 may be placed in the extended position and in fluid-flow communication, through theconduit952, with a reservoir or other fluid source.

By supporting thehousing944 at an injection site (either in thedisposable housing portion20, thedurable housing portion22 or an injection site module), thehousing944 may be arranged adjacent a patient-user's skin (for example, when thedisposable housing portion20, thedurable housing portion22 or the injection site module is arranged adjacent the patient-user's skin, as described above), to allow the sharp end of theneedle950 to pierce the patient-user's skin and to allow thecannula954 to be inserted at least partially into the patient-user's skin, when the needle is in the extended position ofFIG. 30.

In delivery device embodiments described above, a needle injector device is provided on a disposable housing portion (e.g.,20 inFIG. 3), where the disposable housing portion is provided with abase portion21 that may be secured to the patient-user's skin by, for example, but not limited to, an adhesive material provided on the bottom surface of thebase portion21. That arrangement is generally represented, in side view, inFIG. 32, wherein anadhesive material101 is provided on the bottom surface (skin-facing surface) of thebase21 of thedisposable housing portion20. As shown inFIGS. 2,3 and32, thedurable housing portion22 may be configured to be arranged on thebase21 of thedisposable housing portion20 to engage and connect to thedisposable housing portion22. In such an arrangement, thebase21 may be disposed between thedurable housing portion22 and the patient-user's skin, during operation, such that only thebase21 of the disposable housing portion remains in contact with the patient-user's skin, during operation.

However, in other embodiments, thedurable housing portion22 and thedisposable housing portion20 may be configured to engage each other in a side-by-side arrangement, for example, as shown inFIG. 33. In the side-by-side arrangement inFIG. 33, either one or both of thedurable housing portion22 and thedisposable housing portion20 may be provided with an adhesive material101 (and apeelable cover layer23 as shown inFIG. 3).

Also, while embodiments described above may include an on-board needle or cannula injector device as described herein that may be activated through the operator oropening25, other embodiments may employ aninjection site module103 that is external to thedisposable housing portion20, but connected to thedisposable housing portion20, through asuitable conduit102, as shown inFIG. 34. The externalinjection site module103 may include a needle or cannula injector device structure and an operator or opening (similar to the operator or opening25 described above) through which the injector device may be activated. Alternatively or in addition, the externalinjection site module103 may include an infusion set such as, but not limited to an infusion set as described or referenced in U.S. patent application Ser. No. 10/705,686, filed Nov. 10, 2003, titled “Subcutaneous Infusion Set” (Publication No. 2005/0101910) and/or U.S. patent application Ser. No. 11/004,594, filed Dec. 3, 2004, titled “Multi-Position Infusion Set Device And Process” (Publication No. 2006/0129090), each of which is assigned to the assignee of the present invention and each of which is incorporated herein by reference, in its entirety.

Theconduit102 that connects themodule103 with thedisposable housing portion20 may be any suitable tubing structure having a fluid flow passage, such as, but not limited to, a flexible tube made of plastic, silicone or the like. An adhesive material may be provided on the tubing structure (or between the tubing structure and the patient-user's skin) to secure the tubing to the patient-user's skin. By locating theinjection site module103 external to thedisposable housing portion20, thedisposable housing portion20 and thedurable housing portion22 may be clipped to a patient-user's clothing, belt, suspender or other article of apparel or may be held in a pocket of an article of apparel or carried in a purse or the like.

In one embodiment, theconduit102 may be fixed at one end to thedisposable housing portion20, in fluid-flow communication with the reservoir within thedisposable housing portion20, and fixed at a second end to an externalinjection site module103, for connection in fluid-flow communication with a hollow needle or cannula, as described above. In further embodiments, one or both of the ends of theconduit102 may include suitable connection structures that allow the conduit ends to be selectively connected in fluid-flow communication with, and selectively disconnected from thedisposable housing portion20 and/or theinjection site module103. Such connectors may comprise a hollow needle and septum, a Luer connector, or other suitable fluid-communication connectors. In such embodiments, thedisposable housing portion20 and thedurable housing portion22 may be disconnected from themodule103, for example, by disconnecting one of the ends of theconduit102 from themodule103 or thedisposable housing portion20, while leaving themodule103 in place (without requiring the patient-user to withdraw the needle or cannula and, later, insert a needle or cannula to resume operation). In this manner, a patient-user may readily disconnect and remove thedisposable housing portion20 anddurable housing portion22, for example, to allow the patient-user to shower, bath, swim or conduct other activities, yet also allow the patient-user to readily re-connect thedisposable housing portion20 to themodule103, for example, upon completion of such activities.

In yet further embodiments, theconduit102 may be eliminated and aninjection site module103 may be directly connected with thedisposable housing portion20, as shown inFIG. 35. In such an embodiment, one or more suitable fluid flow passages are provided through thedisposable housing portion20 and into theinjection site module103, for fluid-flow communication between the reservoir in thedisposable housing portion20 and a hollow needle or cannula, as described above. Also, in such embodiments, theinjection site module103 and thedisposable housing portion20 may include mating connection structures to allow theinjection site module103 and thedisposable housing portion20 to be selectively connected and disconnected from each other.

Various examples of mating arrangements, for directly connecting aninjection site module103 to a disposable housing portion are described with reference toFIGS. 36-41.FIGS. 36 and 37 show an example arrangement, in which aninjection site module103 includes at least one (two inFIG. 36) protrudingengagement pawl104 that are configured to be received in a corresponding number of receptacles on the disposable housing portion20 (similar to thepawls 74 andreceptacles 76 described in U.S. Patent Application No. 60/839,741, titled INFUSION PUMPS AND METHODS AND DELIVERY DEVICES AND METHODS WITH SAME, filed Aug. 23, 2006, which has been incorporated herein by reference. In other embodiments, the pawl(s)104 may be located on thedisposable housing portion20, while the corresponding receptacles may be located on themodule103. In yet other embodiments, each of thedisposable housing portion20 and themodule103 may include one or more pawls and one or more receptacles.

Thepawls104 and receptacles may be configured to allow a patient-user to manually slide the pawls into the receptacles as thedisposable housing portion20 and themodule103 are brought together. When thepawls104 are received in the corresponding receptacles, themodule103 is secured to thedisposable housing portion20. Thepawls104 may include a shaped portion or head to provide a snap-fit with the receptacles, when thepawls104 are fully received within the receptacles. Thepawls104 may be configured with sufficient flexibility to allow the patient-user to separate thedisposable housing portion20 from themodule103, by applying a sufficient force to pull those two parts away from each other and unsnap thepawls104 from the receptacles. In the embodiment ofFIGS. 36 and 37, themodule103 may be attached to or may include abase portion105 that may be secured to a patient-user's skin during operation, in lieu of the extendedbase21 of thedisposable housing portion20 described above. Thebase portion105 may include an adhesive material and peelable cover layer as described above with respect to thebase21 of thedisposable housing portion20.

Another example of a connection structure is described with reference toFIGS. 38 and 39, wherein themodule103 includes a shapedhead106 configured to be received within a correspondingly shaped opening or receptacle in thedisposable housing portion20. The shapedhead106 may be configured with a shape that allows the head to be received in the receptacle when thedisposable housing portion20 is aligned relative to themodule103 in a first alignment position, as shown inFIG. 37, and further allows thedisposable housing portion20 to be rotated relative to themodule103 while thehead106 is received within the receptacle to a second alignment position as shown inFIG. 39. The receptacle in thedisposable housing portion20 may be shaped to allow thehead106 to be freely received or removed from the receptacle, when thedisposable housing portion20 is in the first alignment position (FIG. 38), yet abut thehead106 and inhibit separation of thehead106 from the receptacle (and, thus, inhibit separation of thedisposable housing portion20 from the module103), when the disposable housing portion is in the second alignment position (FIG. 39).

A further example of a connection structure is described with reference toFIGS. 40 and 41, wherein themodule103 includes a shapedreceptacle107 configured to receive a correspondingly shaped connector member in thedisposable housing portion20. The shapedreceptacle107 may be configured with a shape that allows the connector member of the disposable housing portion to be engaged with thereceptacle107 when thedisposable housing portion20 is aligned relative to themodule103 in a first alignment position, as shown inFIG. 40, and further allows thedisposable housing portion20 to be rotated relative to themodule103, while thereceptacle107 is engaged within the connector member, to a second alignment position as shown inFIG. 41. Thereceptacle107 and the connector member in thedisposable housing portion20 may be shaped to allow the connector member to be freely engage the receptacle454, when thedisposable housing portion20 is in the first alignment position (FIG. 40), yet lock with thereceptacle107 and inhibit separation of the connector member from the receptacle (and, thus, inhibit separation of thedisposable housing portion20 from the module103), when the disposable housing portion is in the second alignment position (FIG. 41). Thereceptacle107 and connection member may include any suitable known rotary connection structures for connecting two structures together upon engagement and relative rotation of the two structures in one direction, yet allow the two structures to be disengaged and separated from an engaged arrangement, by relative rotation of the two structures in the second, opposite direction.

In yet further embodiments, the injection site module may be formed as a unitary structure with thedisposable housing portion20. Also, in any of the embodiments described above, one or more sensors may be located in thedisposable housing portion20, theinjection site module103 or thedurable housing portion22, for sensing a biological condition, including, but not limited to, blood glucose level, level of infusion medium in the patient-user's blood and/or other conditions. Such sensor(s) may include a hollow needle or cannula and/or a set of micro-needles, as described above, for piercing the patient-user's skin to convey fluid from the patient to the sensor.

Also, various embodiments described above may employ areservoir28 that, in some examples, may include a canister that is removable from and insertable into the first ordisposable housing portion20. In this manner, a reservoir cartridge may be removed and replaced with a new, refilled, pre-filled, user-filled, refurbished or remanufactured cartridge. In such embodiments, the reservoir cartridge may include an electronic storage device (such as an electronic memory chip or the like) for storing information, such as, but not limited to, identification of the contents of the reservoir, identification of the maker of the reservoir or its contents, information relating to the state of fill or depletion of the reservoir, or the like. Suitable electrical contact pads located in the disposable housing portion may electrically connect with contact pads on the reservoir, to electrically connect the electronic storage device on the reservoir canister with suitable electronics in the disposable housing portion or thedurable housing portion22, for reading information stored on the electronic storage device. Such information (or other information, warnings, etc., associated with the stored information) may be displayed on a display device on thedurable housing portion22, when the reservoir canister is inserted into thedisposable housing portion20, and thedisposable housing portion20 and thedurable housing portion22 are engaged.

In addition, in any of the above-described embodiments, one or both of thedisposable housing portion20 and the durable housing portion22 (and/or aseparate base portion105 or a separate injection site module103) may include a force sensor (not shown) or other suitable sensing device for sensing the proper placement or engagement of one or more of thedisposable housing portion20 and the durable housing portion22 (and/or a separate base portion or a separate injection site module) on a patient-user's skin (or other proper location for operation with the patient). In such an embodiment, further electronics may control the operation of the drive device to inhibit operation of the drive device and/or the needle injector, unless the sensor senses the proper operable engagement of one or more of thedisposable housing portion20 and the durable housing portion22 (and/or a separate base portion or a separate injection site module) with the patient-user's skin (or other proper location for operation).

Alternatively or in addition, one or both of thedisposable housing portion20 and thedurable housing portion22 may include a sensing device (not shown) for sensing the proper operable engagement of thedisposable housing portion20 and thedurable housing portion22 together (and/or with a separate base portion or a separate injection site module). In such an embodiment, further electronics may control the operation of the drive device to inhibit operation of the drive device and/or the needle injector, unless the sensor senses the proper operable engagement of thedisposable housing portion20 and thedurable housing portion22 together (and/or with a separate base portion or a separate injection site module).

In any of the above embodiments, a sensor may be provided in (or otherwise associated with) the reservoir to detect a low volume of infusion medium in the reservoir. For example, a sensor may be configured to detect a condition at which the volume of infusion medium in the reservoir reaches a threshold minimal level. A warning device may be operably connected to the sensor, to provide a warning signal, upon the detection of a low volume condition. The warning device may provide an audible warning sound, a visible warning signal and/or a tactile warning signal (such as, but not limited to a perceptible vibration) to the patient-user, upon the detection of the volume of infusion medium in the reservoir reaching a threshold minimal level. In one embodiment, the visible warning may be provided as a message on an electronic display (as described above) on thedurable housing portion22. Alternatively or in addition, a warning signal condition may be communicated to and displayed on aremote CCD16 or computer18 (FIG. 2), for example, through wireless communication electronics as described above.

In addition, while various embodiments described above may include one or more adhesive layers, each having a peelable cover layer, other embodiments may employ a single adhesive layer having (or plural adhesive layers, each having) a pattern of plural peelable cover layer portions, such that a patient-user may peel off one portion of the cover layer for adhering the delivery device to the patient-user as described above, while leaving the rest of the pattern of peelable cover layer portions on the adhesive. In such an embodiment, after completion of a first period of operation of the delivery device and removal of the delivery device from the patient-user, a second portion of the peelable cover layer may be removed from the adhesive layer and the delivery device may be adhered to a patient-user for a second period of operation.

Also, while various delivery device embodiments described above include base portions (for example,105) that are configured to be secured to a patient-user's skin (or other suitable surface of operation) and that extend along the full length and width of the delivery device structure, other embodiments may employ base portions (that secure to the patient-user's skin or other surface) that are configured to be less than the full length or width dimension of the delivery device structure, to minimize the surface area in contact with the patient-user (or other surface) and, thus, improve patient-user comfort during operation. Base portions having shapes and sizes different from those shown in the accompanying drawings may be employed for additional improvements with regard to patient-user comfort and minimizing surface area in contact with the patient-user. Furthermore, as noted above, the base portion may be composed of a flexible material that at least partially conforms to the curvature and movement of the patient-user's body.

In any of the above-described embodiments in which an adhesive material is used to secure one or more of the delivery device components to the patient-user's skin (or other suitable surface for operation), multiple types of adhesive materials (or multiple strengths of adhesives) may be employed, such that a stronger adhesive is provided in certain areas (such as around the needle injection site), while a weaker adhesive is provided in other areas.

In any of the above-described embodiments, a priming process may be carried out, prior to activation of the needle inserter, to convey fluid from thereservoir28 to the hollow needle or cannula and/or fill the fluid flow path between thereservoir28 and the hollow needle or cannula. In some embodiments, priming may be carried out before the delivery device (or component of the delivery device that contains the needle inserter) is secured to the patient user's skin. Priming may include running the drive device of the delivery device for a period of time, for example, but not limited to, a period of time until the user observes fluid at the tip of the hollow needle or cannula. In further embodiments, as represented byFIG. 42, a stop-member980 may be provided, temporarily, at the tip of the hollow needle982 (shown inFIG. 42 with acannula984 supported thereon) to allow passage of air out of the needle or cannula, but also provide a back pressure against flow of infusion medium fluid from the needle, for priming. The stop member may be made of or lined with a hydrophobic material, such as, but not limited to a hydrophobic membrane provided under the name GORE-TEXT™ (a trademark of W.L. Gore & Associates, Inc.) or other suitable hydrophobic material. In further embodiments, the stop member may include a further material that changes color (or other perceptible characteristic) when in contact with an infusion medium, to provide a visual indication that priming is completed.

In yet other embodiments of using a hydrophobic material during priming, a needle inserter set may include a removable needle hub that is positioned within a hollow cannula when the cannula is inserted into the patient-user's skin and removed, leaving the cannula in place, after insertion of the cannula, such as, but not limited to a needle set configuration as described in U.S. Pat. No. 4,755,173, which is incorporated herein by reference in its entirety, and/or as employed in products produced by Medtronic, Inc., under the product name Paradigm™ Quick-set™ and Paradigm™ Sof-set™, each of which is a trademark of Medtronic-MiniMed, Inc. or Medtronic, Inc. With reference toFIG. 43, in such embodiments, thehollow needle982 of theneedle hub986 may include ahydrophobic material988 at its tip, for providing a back pressure against fluid flow of liquid infusion medium, but allow air to escape from the hollow needle during priming. In such an embodiment, the interior surface of thehollow needle982 may include a coating or layer ofhydrophobic material988 at or near its piercing end, as shown inFIG. 43. Alternatively, or in addition, a plug of hydrophobic material may be placed in thehollow needle982, for example, at or adjacent the piercing end of the needle. Alternatively, or in addition, astop member980 as described above may be employed during priming, for enhancing back pressure against fluid flow of liquid infusion medium, while allowing air to escape from the hollow needle.

In such an embodiment, prior to insertion of the needle and cannula into a patient-user, the hollow needle extends through the cannula and is visible adjacent one end of the cannula. The drive device of the delivery device may be operated to drive fluid from thereservoir28 to the hollow needle and cannula. The hydrophobic material at the tip of the hollow needle allows passage of air, but inhibits the infusion medium fluid from passing through the hollow needle. Upon running of the drive device for a defined period of time and/or until a completion of priming is detected, the needle and cannula may be inserted into the patient-user. After insertion of the needle and cannula, the needle may be removed from the cannula by withdrawing the needle hub from the remainder of the needle inserter set, leaving the cannula in place within the patient-user's skin and in fluid-flow connection with the reservoir.

Various aspects of the multiple embodiments described above may be employed independently or in combinations thereof. While particular embodiments of the present invention have been shown and described, it will be obvious to those skilled in the art that the invention is not limited to the particular embodiments shown and described and that changes and modifications may be made without departing from the spirit and scope of the claimed invention. For example, while embodiments are described above in the context of delivery devices for delivering an infusion medium from a reservoir to a patient-user, other embodiments may be operated to withdraw a fluidic medium from a patient-user (or other source) and transfer the fluidic medium to the reservoir. Such other embodiments may be operated by operating the drive device to increase the fluid-retaining volume of the reservoir and create a negative pressure sufficient to draw fluid from the patient-user (or other source) to which the hollow needle or cannula is secured.

Claims (32)

1. A needle injector device for connection in fluid-flow communication with the inlet or outlet port of a reservoir, the needle injector comprising:

a base structure for arranging adjacent a user's skin;

a moveable carriage for supporting a hollow cannula for movement between a retracted position and an extended position;

at least one pivotal arm supported on the moveable carriage for pivotal motion relative to the base, between a first pivot position and a second pivot position;

a moveable needle supported by the base structure for movement between a retracted position and an extended position, the moveable needle having a shaft, the needle shaft having a piercing end for piercing the user's skin when the base structure is arranged adjacent the user's skin and the moveable needle is moved to the extended position, wherein the needle shaft has a sufficient length to extend through the cannula to extend the piercing end of the needle out one end of the cannula and move with the cannula between the retracted position and the extended position;

a first spring arranged to provide a first bias force at least when the needle is in the retracted position, the first bias force directed to bias the needle toward the extended position;

a second spring arranged to be held in a compressed state by the at least one pivotal arm, when the at least one pivotal arm is in the first pivot position and the moveable needle is moved to the extended position and, from that state, to be released to expand toward its natural state of uncompression upon the at least one pivotal arm moving to the second pivot position;

wherein, when (i) the base structure is arranged adjacent the user's skin, (ii) the moveable needle and cannula are in the extended position and (iii) the second spring is released from its compressed state and expands toward its natural state of uncompression, a second bias force is provided on the needle by the second spring to move the needle from an extended position to a retracted position, while leaving the cannula in the user's skin.

2. A device according toclaim 1, wherein the base structure has an opening through which the needle moves as the needle is moved between the retracted and extended positions.

3. A device according toclaim 2, wherein the first and second springs comprise first and second coil springs, respectively, and wherein the first and second coil springs are arranged with their coils around the opening in the base structure.

4. A device according toclaim 1, wherein the first and second springs comprise first and second coaxially arranged coil springs, respectively, and wherein the needle is supported for movement within the first and second coil springs.

5. A device according toclaim 4, wherein the needle is arranged to extend along the common axis of the first and second coil springs.

6. A device according toclaim 1, further comprising a flange member arranged to abut the at least one pivotal arm, needle and the second spring when (i) the at least one pivotal arm is in the first pivot position, (ii) the second spring is in its compressed state, and (iii) the needle is in the extended position, and to move with the needle toward the retracted position of the needle when the at least one pivotal arm is moved to the second pivot position to release the second spring.

7. A needle injector device for connection in fluid-flow communication with the inlet or outlet port of a reservoir, the needle injector comprising:

a base structure for arranging adjacent a user's skin;

a moveable carriage for supporting a hollow cannula for movement between a retracted position and an extended position;

at least one moveable locking member supported on the moveable carriage for motion relative to the base, between at least one first position and at least one second position;

a moveable needle supported by the base structure for movement with the moveable carriage between a retracted position and an extended position, the moveable needle having a shaft, the needle shaft having a piercing end for piercing the user's skin when the base structure is arranged adjacent the user's skin and the moveable needle is moved to the extended position,

a first bias member arranged to provide a first bias force on the needle at least when the needle is in the retracted position, the first bias force directed to bias the needle toward the extended position;

a second bias member arranged to be held by the at least one moveable locking member in a state at which the second bias member stores a bias energy when the moveable needle is moved to the extended position and the at least one moveable locking member is in one of the first positions and, from that state, to a state at which the stored bias energy is released to apply a force on the needle to move the needle toward the retracted position, when the at least one moveable locking member is moved to one of the second positions; and

the second bias member being held by the at least one moveable locking member in a state at which the second bias member stores a bias energy when the moveable needle and the carriage are both in the retracted position.

8. A device according toclaim 7, wherein the needle shaft has a sufficient length and width relative to a hollow cannula to extend through the hollow cannula and to extend the piercing end of the needle out one end of the cannula, while supporting the cannula on the needle for movement with the needle between the retracted position and the extended position, and to leave the cannula in the extended position in a user's skin, when (i) the base structure is arranged adjacent the user's skin, (ii) the moveable needle and cannula are in the extended position and (iii) the second bias member is released from its bias energy storing state and moves the needle from its extended position toward its retracted position.

9. A device according toclaim 7, wherein the at least one moveable locking member comprises at least one pivotal arm.

10. A device according toclaim 7, wherein the at least one moveable locking member comprises a plurality of pivotal arms.

11. A device according toclaim 7, wherein the first bias member comprises a spring.

12. A device according toclaim 11, wherein the second bias member comprises a spring.

13. A device according toclaim 7, wherein the first and second bias members comprise first and second coil springs, respectively.

14. A device according toclaim 7, wherein the first and second bias members comprises first and second coaxially arranged coil springs, respectively.

15. A device according toclaim 7, wherein the first and second bias members are supported by the base structure.

16. A device according toclaim 7, wherein the first and second bias members are supported by the base structure and the first and second bias members comprises first and second coaxially arranged coil springs, respectively, and wherein the needle is supported for movement within the first and second coil springs.

17. A device according toclaim 16, wherein the needle is arranged to extend along the common axis of the first and second coil springs.

18. A delivery device for delivering an infusion medium to a user, the delivery device comprising:

a housing structure, the housing structure having an injection site portion;

a reservoir supported by the housing structure, the reservoir having an interior for containing an infusion medium,

a needle injector supported by the injection site portion of the housing structure and connected in fluid flow communication with the interior of the reservoir, the needle injector comprising:

a base structure for arranging adjacent a user's skin;

a moveable carriage for supporting a hollow cannula for movement between a retracted position and an extended position;

at least one moveable locking member supported on the moveable carriage for motion relative to the base, between at least one first position and at least one second position;

a moveable needle supported by the base structure for movement with the moveable carriage between a retracted position and an extended position, the moveable needle having a shaft, the needle shaft having a piercing end for piercing the user's skin when the base structure is arranged adjacent the user's skin and the moveable needle is moved to the extended position,

a first bias member arranged to provide a first bias force on the needle at least when the needle is in the retracted position, the first bias force directed to bias the needle toward the extended position;

a second bias member arranged to be held by the at least one moveable locking member in a state at which the second bias member stores a bias energy when the moveable needle is moved to the extended position and the at least one moveable locking member is in one of the first positions and, from that state, to a state at which the stored bias energy is released to apply a force on the needle to move the needle toward the retracted position, when the at least one moveable locking member is moved to one of the second positions; and

the second bias member being held by the at least one moveable locking member in a state at which the second bias member stores a bias energy when the moveable needle and the carriage are both in the retracted position.

19. A device according toclaim 18, wherein the needle shaft has a sufficient length and width relative to a hollow cannula to extend through the hollow cannula and to extend the piercing end of the needle out one end of the cannula, while supporting the cannula on the needle for movement with the needle between the retracted position and the extended position, and to leave the cannula in the extended position in a user's skin, when (i) the base structure is arranged adjacent the user's skin, (ii) the moveable needle and cannula are in the extended position and (iii) the second bias member is released from its bias energy storing state and moves the needle from its extended position toward its retracted position.

20. A device according toclaim 18, wherein the at least one moveable locking member comprises at least one pivotal arm.

21. A device according toclaim 18, wherein the first and second bias members comprise first and second coil springs, respectively.

22. A device according toclaim 21, wherein the first and second coil springs are arranged coaxially on the base structure.

23. A device according toclaim 1, in which the moveable needle has a needle head, and the second spring is arranged between the moveable carriage and the needle head.

24. A device according toclaim 1, further comprising:

a fluid passage on the base structure and having a port, the fluid passage for conveying fluid between a reservoir and the port; and

a connection structure arranged to connect the cannula in fluid flow communication with the port of the fluid passage when the moveable carriage is in the extended position and to disconnect the cannula from the port of the fluid passage when the moveable carriage is in the retracted position.

25. A device according toclaim 24, wherein the connection structure is supported on the moveable carriage.

26. A device according toclaim 7, in which the moveable needle has a needle head, and the second bias member is arranged between the moveable carriage and the needle head.

27. A device according toclaim 7, further comprising:

a fluid passage on the base structure and having a port, the fluid passage for conveying fluid between a reservoir and the port; and

a connection structure having a fluid flow channel that is separate from and independent of the moveable needle and is arranged to connect a cannula supported by the moveable carriage in fluid flow communication with the port of the fluid passage when the moveable carriage is in the extended position and to disconnect the cannula from the port of the fluid passage when the moveable carriage is in the retracted position.

28. A device according toclaim 27, wherein the connection structure is supported on the moveable carriage.

29. A device according toclaim 1, wherein the second spring is arranged to be held in a state to store energy for the second bias force when the moveable needle is in the retracted position and the at least one moveable locking member is in one of the first positions.

30. A device according toclaim 7, wherein the second bias member is arranged to be held in a state to store a bias energy when the moveable needle is in the retracted position and the at least one moveable locking member is in one of the first positions.

31. A device according toclaim 18, wherein the second bias member is arranged to be held in a state to store a bias energy when the moveable needle is in the retracted position and the at least one moveable locking member is in one of the first positions.

32. A device according toclaim 27, wherein, when the moveable needle is in the extended position, the second bias member imparts a force to move the moveable needle from the extended position to a position at which the needle is outside of the fluid flow channel that connects the cannula in fluid flow communication with the port.

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